MAUDE Adverse Event Report: TRIMED INC. LOCKING CORTICAL SCREW 3.2, 10MM

Model Number	LCBS3.2-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Brock swartz reported on 23 nov 2022 that during a follow-up appointment dr.Akinleye experiences a lcbs3.2-10 screw backing out of the ps5 plate.It was stated this could be due to the thinness of the locking head.The surgeon opted not to address the issue since the patient is asymptomatic.An x-ray of the incident is available.

• Brand Name: LOCKING CORTICAL SCREW 3.2, 10MM
• Common Device Name: LOCKING CORTICAL SCREW 3.2, 10MM
• Manufacturer (Section D): TRIMED INC.; 27533 ave hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED INC; 27533 ave hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 15926620
• Report Number: 2031009-2022-00003
• Device Sequence Number: 20140131
• Product Code: HWC
• UDI-Device Identifier: 00842188106873
• UDI-Public: 00842188106873
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K060041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: LCBS3.2-10
• Device Catalogue Number: LCBS3.2-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LOCKING PLATE, STRAIGHT, 5-HOLE (PS5)
• Patient Age: 74 YR
• Patient Sex: Prefer Not To Disclose