MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; STABLYX, CMC IMPLANT

Model Number	STABLYX, CMC Implant, Sz. 4
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the instructions for use: the following potential risks or discomforts have been associated with carpometacarpal arthroplasty: disassociation, loosening or migration of the prosthesis, infection, erosion and devascularization of the trapezium, material sensitivity reaction, tendon and nerve injuries, undesirable shortening or lengthening of thumb, stiffness of the cmc joint, dislocation or subluxation due to improper positioning, wear and deformation of the articular surfaces, intraoperative and postoperative bone fracture and/or postoperative pain and infection.The device component was not returned for evaluation and all investigations were based on reported information.Based on the investigation results, no definitive relation could be established between the product and the reported adverse consequence.
Event or Problem Description
Implant removal.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: STABLYX, CMC IMPLANT
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; miami, fl
• MDR Report Key: 10340911
• Report Number: 3006742481-2020-00007
• Device Sequence Number: 3458743
• Product Code: KYI
• UDI-Device Identifier: 00841506100340
• UDI-Public: 00841506100340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: STABLYX, CMC Implant, Sz. 4
• Device Catalogue Number: STX-CMA-IS4
• Device Lot Number: AN1704006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/29/2020
• 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: Other
• Patient Age: 56 YR