MAUDE Adverse Event Report: TRIMED, INC. SUPERIOR MIDSHAFT PLATE, RT, 8-HOLE

Model Number	CPSMIDR-8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A trimed sales rep located in (b)(6) reported on 22 oct 2020 that a plate (cpsmidr-8) had to be removed from a patient because of a nonunion.The plate was originally implanted on (b)(6) 2020, and the patient started begin feeling discomfort on (b)(6) 2020.It was determined on (b)(6) 2020 that the plate would need to be removed due to the nonunion.It was stated that the patient was a heavy smoker and not following proper after care instructions.
Event or Problem Description
After the initial report was submitted the device was returned for evaluation, it was determined that the device met trimed's product specifications.It was also determined that the cause of the nonunion was due to the patient being a heavy smoker.

• Brand Name: SUPERIOR MIDSHAFT PLATE, RT, 8-HOLE
• Common Device Name: SUPERIOR MIDSHAFT PLATE, RT, 8-HOLE
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 10880311
• Report Number: 2031009-2020-00005
• Device Sequence Number: 19767644
• Product Code: HRS
• UDI-Device Identifier: 00842188100369
• UDI-Public: 00842188100369
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K112509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: CPSMIDR-8
• Device Catalogue Number: CPSMIDR-8
• Device Lot Number: SY9164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 80