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

Model Number LCBS3.2-10

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Limb Fracture (4518)

Event Date 11/23/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 307774973
• Report Number: 2031009-2022-00003
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00842188106873
• UDI-Public: 00842188106873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LCBS3.2-10
• Device Catalogue Number: LCBS3.2-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LOCKING PLATE, STRAIGHT, 5-HOLE (PS5)
• Patient Age: 74 YR
• Patient Sex: Prefer Not To Disclose