Peri-Loc 73827080Recalls & reported problems
Smith & Nephew, Inc. · PERI-LOC 4.5MM T25 LOCKING SCREW 80MM SELF-TAPPING · Class 2 · Implant
All models of Peri-Loc (102)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556071908), received between Jun 6, 2022 and Jun 13, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
Patient problems
- Failure of Implant2
- Insufficient Information2
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 13, 2022Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY PERFORMED ON (B)(6) 2022, IT WAS NOTICED WITH X-RAYS ON (B)(6) 2022 THAT THE PERI-LOC 4.5MM T25 LOCKING SCREW 74MM SELF-TAPPING WAS FRACTURED. THIS WAS TREATED VIA REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Failure of Implant; Insufficient Information; Nonunion/Delayed-union Bone Fracture
MAUDE report 14681524 ↗InjuryJun 6, 2022Fracture; Fracture
IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY, THE EVOS 2.4MM Y-PLATE 5 HOLE HEAD 7 HOLE SHAFT FRACTURED. IT IS UNKNOWN HOW THIS SITUATION WAS RESOLVED, AS WELL AS THE CURRENT HEALTH STATUS OF THE PATIENT.
Patient problems: Failure of Implant; Insufficient Information; Nonunion/Delayed-union Bone Fracture
MAUDE report 14605077 ↗
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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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