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

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 01/13/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 289524512
• Report Number: 3006742481-2022-00002
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841506101651
• UDI-Public: 00841506101651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2022
• 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
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White