BONE SCREWS 8431.15.040Recalls & reported problems
Limacorporate SPA · Cortical Bone Screw - Flattened Head Dia. 4,5 mm L 40 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 08033390106870), received between Apr 27, 2018 and Apr 27, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Device Operates Differently Than Expected1
- Loose or Intermittent Connection1
Patient problems
- Inadequate Osseointegration1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2018Break; Loose or Intermittent Connection; Device Operates Differently Than Expected
SMR REVERSE SHOULDER PROSTHESIS WAS IMPLANTED USING THE BONE GRAFT SURGICAL TECHNIQUE ON (B)(6) 2017. THE PROSTHESIS WAS REVISED ON (B)(6) 2018 DUE TO FAILURE OF THE BONE GRAFT (CAUSING LOOSENING OF THE METAL BACK + GLENOID PEG FROM GLENOID BONE) AND BREAKAGE OF ONE OF THE BONE SCREWS USED TO FIX THE METAL BACK GLENOID TO THE GLENOID BONE. THE PRODUCT CODE OF THE BONE SCREW IS NOT MARKETED IN THE US. THE PATIENT EXPERIENCED PAIN. THE SURGEON COMMENTED THAT THE BONE GRAFT USED MIGHT HAVE BEEN TOO LARGE. THE EVENT HAPPENED IN (B)(6).
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 7467662 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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