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RESORB X, STERILE 52-310-14-04Recalls & reported problems

KLS-Martin L.P. · MESH, FOIL, PDLLA · Class 2 · Implant

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888118000774), received between Feb 16, 2017 and Feb 16, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Swelling3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 16, 2017Insufficient Device Problem Information

    PATIENT DEVELOPED SORES AND SIGNIFICANT SWELLING 4-9 MONTHS POST-OPERATIVE DIRECTLY OVER IMPLANTS. DOCTOR INDICATED THAT THIS WAS NOT THE NORMAL INFLAMMATORY RESPONSE.

    Patient problems: Swelling

    MAUDE report 6335622 ↗
  • InjuryFeb 16, 2017Insufficient Device Problem Information

    PATIENT DEVELOPED SORES AND SIGNIFICANT SWELLING 4-9 MONTHS POST-OPERATIVE DIRECTLY OVER IMPLANTS. DOCTOR INDICATED THAT THIS WAS NOT THE NORMAL INFLAMMATORY RESPONSE.

    Patient problems: Swelling

    MAUDE report 6335616 ↗
  • InjuryFeb 16, 2017Adverse Event Without Identified Device or Use Problem

    PATIENT DEVELOPED SORES AND SIGNIFICANT SWELLING 4-9 MONTHS POST-OPERATIVE DIRECTLY OVER IMPLANTS. DOCTOR INDICATED THAT THIS WAS NOT THE NORMAL INFLAMMATORY RESPONSE.

    Patient problems: Swelling

    MAUDE report 6335611 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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