Home › PREMIA SPINE LTD › Polyaxial Pedicle Screw
Polyaxial Pedicle Screw
PREMIA SPINE LTD · Model 86392 · UDI-DI 07290014080867
NKB
Prescription
10
510(k) clearances
24,738
Adverse events (86 deaths)
181
Recalls
409
Facilities
Description
Cannulated Polyaxial Pedicle Screw 7.5x60 mm used for fixation of spinal implants to the vertebrae.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-28 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. |
| 2026-05-22 | Innovasis, Inc | Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with unde |
| 2025-09-19 | Orthofix U.S. LLC | Polyaxial screws do not meet performance standards. |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2025-06-30 | SPINEART SA | Cannulated fenestrated polyaxial screws may be incorrectly labeled |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-10-29 | SEASPINE ORTHOPEDICS CORPORATION | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| 2024-08-21 | XTANT Medical Holdings, Inc | Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and |
| 2024-03-15 | SPINEART SA | Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The |
| 2024-02-28 | SEASPINE ORTHOPEDICS CORPORATION | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.