M.U.S.T. Polyaxial Pedicle Screw 03.50.054Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030834417), received between Nov 22, 2017 and Jun 16, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Issue” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2023, AND HAD A REVISION SURGERY ON (B)(6) 2023, DUE TO CAGES MIGRATION. ON (B)(6) 2023 SURGERY PERFORMED TO EXTEND THE CONSTRUCT FROM L3-L5 TO L3-S2AI. DURING THE SURGERY, ONE SCREW IN L5 WAS LOOSE AND THE CROSS-CONNECTOR IN L5 WAS FOUND WITH ONE HOOK LOOSE. THE CROSS-CONNECTOR WAS REMOVED AND REPLACED WITH A NEW ONE, WHILE THE TULIP OF THE SCREW WAS BLOCKED, THEREFORE THE HEAD ADJUSTER HAD TO BE USED TO REMOVE THE SCREW BECAUSE THE SCREWDRIVER CANNOT BE INSERTED IN THE HEAD OF THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY. DELAY TIME WAS 5MIN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17144075 ↗
• InjuryAug 11, 2020Loose or Intermittent Connection

  SPINAL FIXTAION WAS PERFORMED AT L2-L5 FIRSTLY. THE SURGEON ENGAGED THE PEDICLE SCREW WITH THE SCREW DRIVER, BUT HE FELT THE ENGAGE STRENGTH OF THE PEDICLE SCREW AND THE SCREWDRIVER MIGHT BE WEAK. AFTER THE INSERTION OF THE PEDICLE SCREW AND THE ROD, THE SURGEON FELT THE LOOSENING OF THE PEDICLE SCREW AT THE LEFT SIDE OF THE L5, SO THE SURGEON REPLACED THE PEDICLE SCREW AND THE ROD AND PERFORMED THE ADDITIONAL SPINAL FIXTAION. MOREOVER WHEN THE SURGEON ENGAGED THE CROSS CONNECTOR, THE ARM OF THE CROSS CONNECTOR CONTACTED TO THE LAMINA. IN ORDER TO USE IT THE SURGEON PERFORMED ADDITIONAL LAMINA CUT. THE SURGEON DID NOT USE THE CROSS CONNECTOR BECAUSE THE SURGEON WOULD LIKE TO AVOID ADDITIONAL CUT. FINALLY, L2-S1 WAS FIXED. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 25 MINUTES. TOTAL SURGERY TIME WAS ABOUT 150MINS.

  Patient problems: Joint Disorder

  MAUDE report 10389668 ↗
• InjuryNov 22, 2017Device Issue; Device Issue

  THE PATIENT HAD A PRIMARY FUSION OF L3-S1. THE PATIENT CAME IN COMPLAINING OF RIGHT LEG PAIN AND LOWER BACK PAIN. THE PATIENT PRESENTED WITH PSEUDO ARTHRITIS. THE SURGEON DETERMINED THAT THE SCREWS BACKED OUT. THE SURGEON REVISED ALL MEDACTA SCREWS AND RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Arthritis; Pain

  MAUDE report 7052116 ↗