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Simplify® Cervical Artificial Disc
Nuvasive, Inc. · Model E · UDI-DI 00843285100719
MJO
Prescription
0
510(k) clearances
6,148
Adverse events (11 deaths)
15
Recalls
76
Facilities
Description
Simplify® Trial, Size MD, Height 5, 5° Lordosis
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-20 | Centinel Spine, Inc. | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. |
| 2026-03-20 | Centinel Spine, Inc. | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. |
| 2025-12-31 | Centinel Spine, Inc. | Products were mislabeled as the 6mm product but included the 5 mm product. |
| 2024-07-18 | Centinel Spine, Inc. | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluat |
| 2024-07-18 | Centinel Spine, Inc. | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluat |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2022-06-20 | NuVasive Inc | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the in |
| 2021-03-05 | Centinel Spine, Inc. | Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the |
| 2018-03-13 | Medtronic Sofamor Danek USA Inc | The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill gu |
| 2007-09-04 | Medtronic Sofamor Danek USA Inc | Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated. |
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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.