MAUDE Adverse Event Report: SKELETAL DYNAMICS INC. SKELETAL DYNAMICS INC.; GEMINUS DISTAL RADIUS PLATING SYSTEM

Catalog Number GMN-LTS-4HL

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The instructions for use for the geminus distal radius plating system states the following: "all screws must be implanted and fully tightened into the plate to maintain the integrity and strength of the finished construct.If the screws are not attached and/or fully tightened, a non-union, delayed union or construct failure may occur." review of fluoroscopic images from the case revealed that the surgeon did not insert the 3.5mm cortical locking screw, leaving its intended screw hole empty.Discussion with the surgeon further established that they were not following standard practice while preparing the implant site.Under these conditions, the plate failed after five months.

Event Description

An implanted geminus distal radius plate broke 5 months after surgery.

• Brand Name: SKELETAL DYNAMICS INC.
• Type of Device: GEMINUS DISTAL RADIUS PLATING SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer (Section G): SKELETAL DYNAMICS INC.; 7300 n kendall drive; suite 800; miami FL 33156
• Manufacturer Contact: baron villalta ; 7300 n kendall drive; suite 800; miami, FL 33156 ; 3055967585
• MDR Report Key: 18443035
• MDR Text Key: 331932042
• Report Number: 3006742481-2023-00020
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841506101590
• UDI-Public: 00841506101590
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: GMN-LTS-4HL
• Device Lot Number: DM2303143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2023
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White