Torx Threaded Peg TPEG-20Recalls & reported problems
Trimed, INC. · Torx Threaded Peg, 20mm · 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 00842188108389), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Unintended Movement1
Patient problems
- Implant Pain1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement
SALES REP REPORTED ON 11JUL2023 THAT WHEN A SURGEON WAS INSERTING THE LAST TPEG-20 INTO A VLBPR-3-7 THE HEAD OF THE SCREW BROKE OFF. THE SCREW WAS BEING PLACED INTO A BEARING HOLE AND IT WAS NOT INSERTED UNDER POWER. IT WAS REPORTED THAT THE SCREW IS STILL IN THE PATIENT AND LOCKED INTO THE PLATE. THIS DID CAUSE A SLIGHT DELAY IN SURGERY. THE BROKEN SCREW HEAD WAS REMOVED FROM THE PATIENT AND THE SURGEON DOES NOT BELIEVE THAT THE HEAD BREAKING OFF WILL CAUSE THE PATIENT ANY ADDITIONAL HARM. THE HEAD OF THE SCREW WAS DISCARDED, ONE PICTURE WAS PROVIDED, HOWEVER X-RAYS ARE NOT AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 10SEP2023 THAT A REVISION SURGERY WAS DONE ON (B)(6) 2023 TO REMOVE THE PLATE AND SCREW CONSTRUCT DUE TO PATIENT DISCOMFORT. IT WAS REPORTED THAT THE REP IS UNSURE IF THE PATIENT WAS WEIGHT BEARING TOO EARLY.
Patient problems: Implant Pain; Pain
MAUDE report 17733481 ↗
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- NA 03.010.440Synthes GmbH · NAIL, FIXATION, BONE70 reports
- TRIGEN 71676627Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall2 reports
- TRIGEN 71676628Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall0 reports
- NA 03.043.018Synthes GmbH · NAIL, FIXATION, BONE33 reports
- TRIGEN 71675383Smith & Nephew, Inc. · NAIL, FIXATION, BONE29 reports
- NA 03.010.441Synthes GmbH · NAIL, FIXATION, BONE27 reports
- NA 03.010.435Synthes GmbH · NAIL, FIXATION, BONE24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.