Polyaxial Pedicle Screw 86139Recalls & reported problems
Premia Spine Ltd · Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x50 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290014064935), received between Feb 17, 2022 and Feb 17, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Patient-Device Incompatibility1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2022Fracture; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Fracture; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
THE COMPANY WAS INFORMED ABOUT A REVISION SURGERY IN (B)(6) OF A PROMIS SYSTEM SCHEDULED FOR (B)(6) 2022 DUE TO PATIENT COMPLAINTS OF PAIN AND NOISES FROM HER BACK. DURING THE SURGERY, SURGEON DETERMINED THAT FUSION WAS ACHIEVED AND THE INSTRUMENTATION WAS REMOVED. UPON REMOVAL OF THE PEDICLE SCREWS, ONE PEDICLE SCREW IN S1 WAS FOUND BROKEN. THE PEDICLE SCREW HEAD WAS RETRIEVED, AND THE SCREW BODY REMAINED IN-SITU. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT IS DOING WELL.
Patient problems: Pain
MAUDE report 13548758 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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