Peri-Loc 71805245Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010521729), received between Jul 15, 2020 and Jul 15, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033669, K210837); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryJul 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON WAS HAND TIGHTENING A PERILOC 4.0 X 45MM FULLY THREADED CANCELLOUS SCREW IN TO THE PATIENT'S TIBIA WHEN THE HEAD OF THE SCREW BROKE. THE BROKEN PART FELL INSIDE THE PATIENT AND COULD NOT BE RETRIEVED SUCCESSFULLY. A DELAY OF 0 TO 30 MINUTES REPORTED. AN S&N BACKUP WAS AVAILABLE. NO ADDITIONAL PATIENT INJURIES REPORTED, OTHER THAN THE BROKEN PIECE REMAINING INSIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10280698 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033669, K210837. One submission often covers many models, so check the product and lot details in each record.

• Z-2314-2010 · Jul 20, 2010 · Terminated
  PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 71800710, QTY: (1), STERILE R, CE 0086, Smith & Nephew, Inc., Memphis, TN 38116, USA, EC REP: