Skip to content

TSRH® Spinal System 83565508Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SCREW 83565508 TSRHOGTHINSHORTMPA6.5X50 · Class 2 · Implant

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 00613994568502), received between Jan 17, 2019 and Jan 17, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration or Expulsion of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryJan 17, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE SCOLIOSIS WITH MULTILEVEL STENOSIS, DEGENERATIVE DISC DISEASE (DDD) AND UNDERWENT MULTILEVEL LAMINECTOMY FUSION SURGERY AT T11- ILEUM LEVELS. POST-OPERATIVELY, THE SCREW LOOSENED. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO REMOVE THE ALLEGED SCREW. NO PATIENT COMPLICATIONS WERE REPORTED POST SURGERY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8255679 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.