MTP Plate, 5 Holes, Left MFP 012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118105019), received between Jan 23, 2019 and Jan 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

1 other recall cover devices cleared under the same FDA submission (K131657); 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 18, 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.

• InjuryJan 23, 2019Deformation Due to Compressive Stress; Detachment of Device or Device Component; Patient Device Interaction Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Patient Device Interaction Problem

  MTP PLATE(MFP 012, LOT 1701320000) IMPLANTED ON (B)(6) 2018 BROKE; REVISION SURGERY HAPPENED ON (B)(6) 2019. DURING THE REMOVAL, THERE WAS ALSO A REPORT OF BLACKNESS SURROUNDING THE PLATE, WHICH THE DOCTOR BELIEVED COULD BE "METALOSIS".

  Patient problems: Osteolysis; Pain; Patient Problem/Medical Problem

  MAUDE report 8271301 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131657. One submission often covers many models, so check the product and lot details in each record.

• Z-1314-2015 · Feb 16, 2015 · Terminated
  Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm