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TECHTONIX 48202234Recalls & reported problems

Stryker Corporation · 22-34 mm PLATE SHORT MEDIUM · 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 04546540443144), received between Oct 24, 2016 and Oct 24, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Difficult to Remove1

Patient problems

  • Injury1
  • No Code Available1
  • Pain1

Recent adverse event reports

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

  • InjuryOct 24, 2016Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT; THERE IS A PATIENT COMPLAINT AND REQUESTED US TO CONTACT WITH THE PATIENT. PATIENT (B)(6) IS CONTACTED BY RAQA MANAGER AND AREA MANAGER TURKEY AND THE FOLLOWING INFORMATION IS RECEIVED; PATIENT HAD THE FIRST SURGERY IN 2012 PLATES.THE REASON OF THE FIRST SURGERY WAS DISC DEGENERATION & STENOSIS. HE HAD A SHORT OPERATION WITH LOCAL ANESTHESIA IN 2013 BECAUSE OF HIS PAINS, IN 2015, HE NEEDED TO HAVE ANOTHER SURGERY. THE SURGERY TOOK 4.5 HOURS AND THE DOCTOR INFORMED THE PATIENT THAT THEY OPENED HIM BUT COULD NOT DO ANYTHING BECAUSE THEY COULDN¿T GET THE IMPLANTS OUT. HE TRIED TO REMOVE THE IMPLANTS WITH OTHER INSTRUMENT SET, BUT COULD NOT MANAGE. DOCTOR ALSO TOLD TO THE PATIENT THAT, THEY TRIED TO REACH THE DISTRIBUTOR AND THE DISTRIBUTOR TOLD THAT THESE PRODUCTS WERE OUT OF MARKET. ( DISTRIBUTION AGREEMENT WAS TERMINATED BY DEC 2012.) IMPLANTS IN THE PATIENT WERE DAMAGED DURING THIS SURGERY. DOCTOR ALSO TOLD THE PATIENT THAT, EVEN IF HE CAN FIND THE INSTRUMENTS, HE CAN¿T PERFORM THE SURGERY. PATIENT¿S 3RD SURGERY WAS DONE AND SURGEON ONLY COULD LOOSENED HIS NERVES. THE PATIENT IS SUFFERING NOW AND THE SURGEONS TOLD HIM THAT HE CAN¿T BEAR THE 4TH SURGERY, IF HE

    Patient problems: Injury; No Code Available; Pain

    MAUDE report 6052680 ↗

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