LCP 02.112.208Recalls & reported problems
Synthes GmbH · 3.5MM LCP POSTERIOR DISTAL TIBIA T-PLATE/8 HOLE/132MM · Class 2 · Implant
All models of LCP (367)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886982034410), received between Mar 14, 2018 and Mar 14, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS SEEN IN CLINIC ON (B)(6) 2018 FOR INFECTED NONUNION OF HARDWARE. THERE IS A PLANNED SURGERY ON (B)(6) 2018. REVISION SURGERY TOOK PLACE ON (B)(6) 2018. INITIALLY THE PATIENT HAD A MOTORCYCLE ACCIDENT AND HE UNDERWENT A SURGERY AT AN OUTSIDE HOSPITAL FOR OPEN DISTAL TIBIA FRACTURE AND PELVIS FRACTURE ON (B)(6) 2017. PELVIS WAS EXFIXED ALONG WITH TIBIA EXFIX AND DEBRIDEMENT. ON (B)(6) 2017 TIBIA DEBRIDEMENT AND ORIF PUBIC SYMPHYSIS WAS DONE. AGAIN ON (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2017 TIBIA DEBRIDEMENT WAS DONE. ON (B)(6) 2017, ORIF OF DISTAL TIBIA AND CROSS FLAP GRAFT FROM RIGHT LEG WAS DONE AND THE LEGS WERE EXFIXED TOGETHER. THE EXFIX WAS REMOVED APPROXIMATELY 2-3 WEEKS LATER. THE PATIENT WAS THEN IMPLANTED WITH ONE LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM, ONE 3.5MM LCP POSTERIOR DISTAL TIBIA T-PLATE/8 HOLE/132MM AND SEVENTEEN UNKNOWN SCREWS ON AN UNKNOWN DATE IN (B)(6) 2017. DURING THE REVISION SURGERY ON (B)(6) 2018 FOR INFECTED NON-UNION OF THIS IMPLANTED HARDWARE, THE PATIENT RECEIVED A LEFT BELOW THE KNEE AMPUTATION. SINCE THE LOWER LEG WAS AMPUTATED, ALL THE DEVICES REMAINED INTACT W
Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection
MAUDE report 7340324 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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