NA 3550S-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994747204), received between May 30, 2018 and May 30, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Or Device Fragments Location Unknown” (1 report).

1 other recall cover devices cleared under the same FDA submission (K001096); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2018Device Or Device Fragments Location Unknown; Unintended Movement; Device Or Device Fragments Location Unknown; Unintended Movement

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IM PLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT IN THE PROCESS OF PLACING THE SCREWS TO FIXATE THE STIMLOC, THE SCREWS OUT OF THE LEAD KIT EITHER BROKE OR WOULD NOT BITE THE DRILL DEEP ENOUGH FOR COMPLETE SEATING IN THE SKULL, FURTHER STATING THAT EACH TIME THE STIMLOC HAD TO BE REPOSITIONED AND THIS HAPPENED THREE TIMES. 1/2 SCREWS PURCHASED APPROPRIATELY, THE SECOND SCREW DID NOT AND THE TIP MAY HAVE BROKEN, THEY BACKED OUT SCREWS, REPOSITIONED STIMLOC AND ATTEMPTED USING TWO NEW SCREWS, AND THE SAME ISSUE OCCURRED. THERE WERE NO ENVIRONMENT/EXTERNAL OR PATIENT FACTORS THAT WOULD HAVE LED OR CONTRIBUTED TO THE ISSUE. IT WAS REPORTED THAT THEY TRIED USING THE NEW DISPOSABLE STIMLOC DRIVER WITH DIFFERENT SCREWS BUT THAT DID NOT REMEDY, HOWEVER THEY REPLACED WITH ADDITIONAL SINGLE SCREW AND IT FINALLY PURCHASED. BOTH SCREWS FINALLY SEATED COMPLETELY AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ONE OF THE SCREWS MISFIRED, WOULD NOT BITE AND WAS PARTIALLY EXPLANTED. NO PATIENT SYMPTOMS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554031 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001096. One submission often covers many models, so check the product and lot details in each record.

• Z-2228-2021 · Jun 2, 2021 · Open, Classified
  Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000