MAUDE Adverse Event Report: LIMACORPORATE S.P.A. BONE SCREWS; BONE SCREWS DIA. 6.5 H.30MM

Model Number	8420.15.030
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts, no pre-existing anomaly was discovered in the items belonging to the same product codes and lot numbers as those of the components involved in this event.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Patient developed an infection post on (b)(6) 2022 hip surgery and had a surgical washout procedure.The implant was not removed.Then on (b)(6) 2022, the patient presented with pain and x-rays show that the screw fixation failed and the implant is disassociated from the acetabulum.The correct date of the revision surgery is currently unknown.According to the information provided, the components involved in this event are the following: bone screw ø6,5 h.30mm (part code: 8420.15.030, lot number: 2114144, sterilization: 2100225) bone screw ø6,5 h.35mm (part code: 8420.15.040, lot number: 2114894, sterilization: 2100236) bone screw ø6,5 h.50mm (part code: 8420.15.070, lot number: 2105840, sterilization: 2100171) bone screw ø6,5 h.60mm (part code: 8420.15.090, lot number: 2023272 / 1805396, sterilization: 2100057 / 1800136).The patient is a female, date of birth on (b)(6) 1957.The event happened in the united states.

• Brand Name: BONE SCREWS
• Common Device Name: BONE SCREWS DIA. 6.5 H.30MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 24207336
• Report Number: 3008021110-2026-00114
• Device Sequence Number: 5558191
• Product Code: MBL
• UDI-Device Identifier: 08033390018869
• UDI-Public: 08033390018869
• Combination Product (Y/N): N
• PMA/510(K) Number: K172456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 8420.15.030
• Device Lot Number: 2114144
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown