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OmniPore Surgical Implant OP82011Recalls & reported problems

Matrix Surgical Holdings, LLC · Craniotomy Gap Wedges (2 pk) · Class 2 · Implant

All models of OmniPore Surgical Implant (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855421005727), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K123908); 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

Device problems

  • Unsealed Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 25, 2017Unsealed Device Packaging; Unsealed Device Packaging

    ON SEPTEMBER 27, 2017, IT WAS REPORTED BY OUR CONTRACT DISTRIBUTOR (B)(4) IN (B)(4) THAT THE OUTER POUCH FOR PART CRANIOTOMY GAP WEDGES (OP82011); LOT 00855421005727 018141116 WAS NOT SEALED. NO PATIENT OR END USER INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 6977258 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123908. One submission often covers many models, so check the product and lot details in each record.

  • Z-1223-2019 · Jan 30, 2019 · Terminated
    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
  • Z-1224-2019 · Jan 30, 2019 · Terminated
    OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
  • Z-1382-2017 · Jan 25, 2017 · Terminated
    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page