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Malibu
Seaspine Orthopedics Corporation · Model MLBDHIMP · UDI-DI 10889981028121
MQP
Prescription
1
510(k) clearances
2,934
Adverse events (14 deaths)
46
Recalls
226
Facilities
Description
Malibu Deformity Hook Implant. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-10 | NuVasive Inc | Potential that insert will be unable to disengage from the vertebral body replacement device/implant |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
| 2020-09-21 | Synthes (USA) Products LLC | Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device" |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.