BONE SCREWS 8432.15.030Recalls & reported problems
Limacorporate SPA · Cortical Bone Screw - Flattened Head Dia. 5 mm L. 30 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 08033390196901), received between Sep 17, 2026 and Sep 17, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Break
Revision surgery performed on 2nd September 2026 due to breakage of screw. On X-ray taken on 31st August 2026 revealed that a screw had broken. During the revision procedure, all implant components were removed from the patient's body. No information is available regarding any traumatic event that may have contributed to the occurrence.Previous surgery was performed on (b)(6)2025. Hereby the devices implanted on previous surgery ((b)(6) 2025). During the revision surgery, all devices were removed except for the stem, and no new implants were inserted. There were three screws implanted and we do not know which one was broken: · CORTIC.BONE SCREW D.5 L.26 MM (Product Code: 8432.15.026 - Lot: 2108014). · CORTIC.BONE SCREW D.5 L.30 MM (Product Code: 8432.15.030 - Lot: 2408956). · CORTIC.BONE SCREW D.5 L.30 MM (Product Code: 8432.15.030 - Lot: 2511464) · SMR REVERSE HUMERAL BODY (Product Code: 1352.20.010 - Lot: 2505566) . · SMR REVERSE LINER + 6 MM (Product Code: 1360.50.020 - Lot: 24AT4WN) . · SMR CONNECTOR SMALL R (Product Code: 1374.15.305 - Lot: 2501649) . · SMR ECCENT. GLENOSPHERE Ø 36MM (Product Code:1376.15.031 - Lot: 2504663) . · TT AUGM.360 BASEPLATE #S-R 7° (Product Code: 137
Patient problems: Insufficient Information
MAUDE report 50803163 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
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- 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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