Polyaxial Pedicle Screw 86138Recalls & reported problems
Premia Spine Ltd · Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 7.5x45 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290014064928), received between Apr 24, 2023 and Nov 22, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
- Fracture1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
PATIENT IMPLANTED WITH THE PROMIS FIXATION SYSTEM IN GERMANY, UNDERWENT A SECOND REVISION SURGERY TWO MONTHS AFTER THE FIRST REVISION DUE TO ANOTHER SCREW LOOSENING. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2023 DUE TO STENOSIS AND SPONDYLODISCITIS AND INCLUDED FUSION AT L5-S1. IN THE FIRST REVISION SURGERY, TWO PEDICLE SCREWS IN S1 VERTEBRA WERE REPLACED BY TWO NEW LARGER DIAMETER PEDICLE SCREWS. L5 SCREWS REMAINED IN-SITU AND RODS WERE RE-USED. IN THE SECOND REVISION SURGERY, TWO PEDICLE SCREWS IN S1 VERTEBRA WERE REPLACED BY TWO NEW LONGER PEDICLE SCREWS. L5 SCREWS REMAINED IN-SITU AND RODS WERE REPLACED WITH NEW IDENTICAL RODS. ACCORDING TO THE SURGEON WHO PERFORMED BOTH REVISION PROCEDURES, THE REASON FOR SCREW LOOSENING WAS BONE DISEASE (SPONDYLODISCITIS).
Patient problems: Insufficient Information
MAUDE report 18190215 ↗InjuryApr 24, 2023Fracture; Fracture
THE COMPANY RECEIVED TWO BROKEN PEDICLE SCREWS THAT WERE EXPLANTED IN A REVISION SURGERY OF THE PROMIS SYSTEM IN THE US. THE EXPLANTS ARRIVED IN A PLASTIC CONTAINER, LABELED WITH THE PATIENT INITIALS AND DATE OF BIRTH WHICH ALLOWED TRACEABILITY TO THE ORIGINAL PROCEDURE. THE ORIGINAL PROCEDURE WAS PERFORMED ON 02.05.2016 AND WAS A 5-LEVEL FUSION FROM L2 TO S1. THE INVOLVED SCREWS (7.5X45MM) WERE IMPLANTED IN THE S1 LEVEL. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE ORIGINAL OR REVISION SURGERIES, PATIENT'S CLINICAL BACKGROUND AND OTHER RELEVANT CLINICAL INFORMATION DESPITE MULTIPLE ATTEMPTS TO RECEIVE INFORMATION FROM THE SURGEON WHO PERFORMED THE INDEX AND REVISION SURGERIES.
Patient problems: Insufficient Information
MAUDE report 16795535 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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