Polyaxial Pedicle Screw 86132Recalls & reported problems
Premia Spine Ltd · Polyaxial Pedicle Screw Cannulated, Torx Setscrew, Grooved 6.5x50 mm · Class 2 · Implant
Data updated Oct 16, 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 07290014064898), received between Oct 3, 2023 and Oct 3, 2023 — classified as 1 injury.
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
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
PATIENT IMPLANTED WITH THE PROMIS FIXATION SYSTEM IN GERMANY, UNDERWENT REVISION SURGERY AFTER 6 WEEKS DUE TO SCREW LOOSENING. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6), 2023 DUE TO STENOSIS AND SPONDYLODISCITIS AND INCLUDED FUSION AT L5-S1. IN THE 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. ACCORDING TO THE SURGEON WHO PERFORMED THE REVISION PROCEDURE, THE REASON FOR SCREW LOOSENING WAS SPONDYLODISCITIS.
Patient problems: Insufficient Information
MAUDE report 17860254 ↗
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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 13, 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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