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
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- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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