MAUDE Adverse Event Report: SKELETAL DYNAMICS, INC. GEMINUS VOLAR DISTAL RADIUS PLATE; SKELETAL DYNAMICS VOLAR DISTAL RADIUS PLATE

Model Number	GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, Right
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that the device failure may have occured due to an installation error and failure to follow post-op procedure.It was noted that not all screws were installed.As per instructions for use, a non-union or implant failure may occur if not all screws are present.Patient was "very active and not very compliant", and admitted to lifting heavy weights at work.The product was not returned for evaluation.Based on information provided and investigation performed, this does not appear to be a device malfunction.
Event or Problem Description
All screws installed in the heads of the plate were fractured post-implantation.Implant collapse and fracture displacement was confirmed via florouscopy 3 months post-implantation.

• Brand Name: GEMINUS VOLAR DISTAL RADIUS PLATE
• Common Device Name: SKELETAL DYNAMICS VOLAR DISTAL RADIUS PLATE
• Manufacturer (Section D): SKELETAL DYNAMICS, INC.; 7300 north kendall drive; suite 400; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS, INC.; 7300 north kendall drive; suite 400; miami FL 33156
• Manufacturer Contact: alejandro ros ; 7300 north kendall drive; suite 400; miami, FL 33156 ; 3055957585
• MDR Report Key: 13519161
• Report Number: 3006742481-2022-00002
• Device Sequence Number: 4158664
• Product Code: HRS
• UDI-Device Identifier: 00841506101651
• UDI-Public: 00841506101651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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
• Device Model Number: GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, Right
• Device Catalogue Number: GMN-RTS-4HL
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 42 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White