MAUDE Adverse Event Report: SKELETAL DYNAMICS IMPLATE; WRIST ARTHRODESIS NAIL SYSTEM

Model Number	IMPLATE Nail, Metacarpal, Mini
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint part is not expected to be returned for review/investigation.Device lot number was not provided and therefore a thorough review of device records could not be conducted.Attempts made to get additional information were unsuccessful.Based on the limited information available, no conclusion can be drawn.No trend has been identified at the time of this submission.This type of failure mode will continue to be monitored.
Event or Problem Description
Screw loosening post-op.

• Brand Name: IMPLATE
• Common Device Name: WRIST ARTHRODESIS NAIL SYSTEM
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• MDR Report Key: 12457220
• Report Number: 3006742481-2021-00008
• Device Sequence Number: 3935511
• Product Code: HSB
• UDI-Device Identifier: 00841506102153
• UDI-Public: 00841506102153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/12/2021

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: IMPLATE Nail, Metacarpal, Mini
• Device Catalogue Number: IMP-MCN-M40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/10/2021
• 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