MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; INTERNAL JOINT STABALIZER

Model Number	IJS-E Base Plate Assembly
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device problems were identified.Revision procedure was successfully completed and no problems have been identified.The instructions for use for the system states: " improper placement, positioning, alignment or fixation of the ijs-e construct may result in unusual stress conditions which may lead to subsequent reduction in the service life of the components, construct failure, postoperative complications or ineffective treatment.".
Event or Problem Description
Detachment of connecting rod.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: INTERNAL JOINT STABALIZER
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• MDR Report Key: 10623420
• Report Number: 3006742481-2020-00009
• Device Sequence Number: 3620192
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2020

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: IJS-E Base Plate Assembly
• Device Catalogue Number: IJS-ELB-BPA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 10/02/2020
• 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: 41 YR
• Patient Weight: 102