MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; MIDSHAFT ULNA PLATE

Catalog Number	MUP-157
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use for the forearm plating system (which includes midshaft ulna plates) states the following: "the set is to be used only with skeletal dynamics instruments, implants, and accessories." accessories not provided by skeletal dynamics or indicated for use with this plate were implanted with the device, which may have negatively impacted the fracture site.Without proper healing, the plate failed after 18 months.
Event or Problem Description
An implanted midshaft ulna plate broke 18 months after surgery.

• Brand Name: SKELETAL DYNAMICS INC.
• Common Device Name: MIDSHAFT ULNA PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 400; miami, FL 33156
• MDR Report Key: 17390072
• Report Number: 3006742481-2023-00013
• Device Sequence Number: 6808770
• Product Code: HRS
• UDI-Device Identifier: 00841506115399
• UDI-Public: 00841506115399
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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 Catalogue Number: MUP-157
• Device Lot Number: DM2010037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male