LCP 02.112.109SRecalls & reported problems
Synthes GmbH · 2.7MM/3.5MM LCP POSTLAT DSTL FIBULA PL 4H/LEFT/90MM-STER · Class 2 · Implant
All models of LCP (367)
Data updated Oct 18, 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 10886982033406), received between Sep 16, 2024 and Sep 16, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Impaired Healing1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT SURGERY TO FRACTURE REPAIR OF AN OPEN, DISPLACED, COMPLEX (COMMINUTED) FRACTURE OF THE DISTAL TIBIA ON THE RIGHT SIDE USING TWO 3.5MM HEADED TITANIUM SCREWS 42MM LONG WITH LONG THREAD WITH SUPPLEMENTAL FIXATION USING A DEPUY SYNTHES 2.4MM VARIABLE ANGLE LCP DORSAL DISTAL RADIUS T-PLATE WITH A 3-HOLE HEAD AND A 5-HOLE SHAFT (51MM LONG, STAINLESS STEEL). SUBJECT ALSO UNDERWENT A FRACTURE REPAIR OF THE FIBULA AND RECEIVED A DEPUY SYNTHES 2.7MM/3.5MM LCP POSTEROLATERAL DISTAL FIBULA PLATE (4 HOLES, 90MM IN LENGTH, LEFT ORIENTATION, MADE OF STAINLESS STEEL). OPERATING ROOM TIME WAS 60 MINUTES. POST-OPERATIVE TREATMENT: BRACING/IMMOBILIZATION: NON WEIGHT BEARING FOR 10 WEEKS, PARTIAL WEIGHT BEARING UNTIL 12 WEEKS POST OP IN A BOOT, FULL WEIGHT BEARING IN A GYM SHOE AT 12 WEEKS POST OP; AT 4.5 MONTHS POST-OPERATIVE PATIENT HAD HARDWARE REMOVAL AND WAS INSTRUCTED TO WEIGHTBEAR AS TOLERATED; PAIN MEDICATION: HYDROCODONE ACETAMINOPHEN (5-325MG TAKEN EVERY 4 HRS OR AS NEEDED FOR 2 MONTHS), CLINDAMYCIN (300MG 3X/DAY FOR 10 DAYS STARTING 4 WEEKS POST-OPERATIVE) TO PREVENT INFECTION. WAS TAKING GABAPENTIN (400MG ONCE DAILY FOR SEIZUR
Patient problems: Impaired Healing; Pain; Unspecified Infection
MAUDE report 20223358 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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