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INVISx™ 60101Recalls & reported problems

Medtronic Ps Medical, Inc. · LOCKS 60101 INVISX - 1 · Class 2 · Implant

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 00643169466296), received between Nov 11, 2021 and Nov 11, 2021 — classified as 1 injury.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryNov 11, 2021Break; Break

    IT WAS REPORTED THE DEVICE BROKE DURING USE. THE DEVICE WAS PLANNED TO BE EXPLANTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12799242 ↗

Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices

All PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.