MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PRIMA; PRIMA - 2MM ECCENTRICAL ADAPTOR WITH SCREW

Model Number	1367.15.702
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation the investigation on this event is currently ongoing and the manufacturer will send a follow up mdr as soon as possible.
Event or Problem Description
Intra-operative issue was discovered during a surgery performed on (b)(6)2025, related to the following component: - prima 2mm eccentrical adaptor (part code 1367.15.702, lot number 2416658, sterilization 2400195).The black laser marking meant to identify the position of the offset is reported as not present in the last 2 cases.The surgeon proceeded anyway to implant the device.The patient involved in the event is a female, date of birth (b)(6)1948.The event happened in the united states.

• Brand Name: PRIMA
• Common Device Name: PRIMA - 2MM ECCENTRICAL ADAPTOR WITH SCREW
• 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: 21934152
• Report Number: 3008021110-2025-00042
• Device Sequence Number: 12069250
• Product Code: HSD
• UDI-Device Identifier: 08033390201827
• UDI-Public: 08033390201827
• Combination Product (Y/N): N
• PMA/510(K) Number: K212800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1367.15.702
• Device Lot Number: 2416658
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• 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