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NewPort™
Seaspine Orthopedics Corporation · Model NWD2IMP · UDI-DI 10889981028206
MQP
Prescription
1
510(k) clearances
2,934
Adverse events (14 deaths)
46
Recalls
226
Facilities
Description
NewPort Deployer 2 Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. 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.