MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BONE SCREWS; CORTICAL BONE SCREW - FLATTENED HEAD DIA. 4,5 MM L 26 MM

Model Number	8431.15.026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2026.The exact reason for revision is not clear, but possible infection was reported.No new implants were implanted during this procedure.The patient has a girdlestone situation.Previous surgery performed on (b)(6) 2022.Following the devices explanted: cmd 22-1070 glenoid implant (product code: 9618140hc, lot: 2209828 - ster: (b)(4) , smr reverse hp liner short (product code:136209010, lot:2024152 - ster: (b)(4), smr reverse humeral body (product code:135220010, lot: 2204557 - ster: (b)(4), cortic.Bone screw d.4,5 l.26mm (product code: 843115026, lot: 2008183 - ster: (b)(4), smr reverse hp glenosph.44 mm (product code:137450440, lot: 2205022 - ster: (b)(4), cortic.Bone screw d.4,5 l.32mm (product code: 843115032, lot: 1918239 - ster: (b)(4), cortic.Bone screw d.4,5 l.28mm (product code: 843115028, lot: 2110540 - ster: (b)(4).Patient male, 65 years old, bmi 26.87.Event occurred in germany.
Additional Manufacturer Narrative
The device history records (dhrs) and sterilization charts for the lot numbers involved have been reviewed; no pre existing anomalies were identified.A final report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
The device history records (dhrs) and sterilization charts for the involved lot numbers were reviewed, and no pre existing anomalies were identified.The complaint source provided several x rays and supporting documents, including operative notes and microbiological test results.All available documentation was forwarded to a medical expert for evaluation.The expert stated: "the case is a clear infection problem with septic loosening.The radiographs show severe bone erosion in the early years around the stem at the proximal humerus.Although this can have other reasons, most of the time it is related to the infection.In the end the sample taken on 09th february 2026 identified cutibacterium acnes and confirmed infection.There is no sign for implant related failure.It is a fateful course of events." based on the information reviewed, it is not possible to determine the root cause of the event.However, considering that: · the dhr review did not reveal any pre existing anomalies.· the medical expert confirmed the reported infection and found no indication of implant related failure.We conclude that the event is not product related.Pms data according to our pms data, the revision rate for infection associated with smr reverse implants is approximately 0.067%.Cmd 22 1070 is a unique device manufactured for a specific patient; therefore, no indicative revision rate can be calculated.This is a final mdr report.
Event or Problem Description
Revision surgery performed on (b)(6) 2026.The exact reason for revision is not clear, but possible infection was reported.No new implants were implanted during this procedure.The patient has a girdlestone situation.Previous surgery performed on (b)(6) 2022.Following the devices explanted: cmd 22-1070 glenoid implant (product code: 9618140hc, lot: 2209828 - ster: 2200121).Smr reverse hp liner short (product code:136209010, lot:2024152 - ster: 2100088).Smr reverse humeral body (product code:135220010, lot: 2204557 - ster: 2200095).Cortic.Bone screw d.4,5 l.26mm (product code: 843115026, lot: 2008183 - ster: 2000219).Smr reverse hp glenosph.44 mm (product code:137450440, lot: 2205022 - ster: 2200081).Cortic.Bone screw d.4,5 l.32mm (product code: 843115032, lot: 1918239 - ster: 1900386).Cortic.Bone screw d.4,5 l.28mm (product code: 843115028, lot: 2110540 - ster: 2100384).Patient male, 65 years old, bmi 26.87.Event occurred in germany.

• Brand Name: BONE SCREWS
• Common Device Name: CORTICAL BONE SCREW - FLATTENED HEAD DIA. 4,5 MM L 26 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24444031
• Report Number: 3008021110-2026-00155
• Device Sequence Number: 10443599
• Product Code: MBF
• UDI-Device Identifier: 08033390106795
• UDI-Public: 08033390106795
• Combination Product (Y/N): N
• PMA/510(K) Number: K191746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8431.15.026
• Device Catalogue Number: 8431.15.026
• Device Lot Number: 2008183
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Unknown