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

Model Number	IJS-E Base Plate Assembly
Medical Device Problem Codes	Break (1069); Off-Label Use (1494)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use for the system states the indications for use as: "the ijs-e system is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.For safe effective use of the implant, the surgeon must be thoroughly familiar with the surgical technique for the device, implant, and associated instruments.Potential ijs-e construct failures such as stress fractures of the bones, loosening of the construct, instability, delayed soft tissue healing, soft tissue irritation, or incomplete healing may occur as a result of non-compliance to post-operative rehabilitation, excessive elbow activities or construct overloading." furthermore, this device contraindications state: "the ijs-e system should not be used if the following are present: active or latent infection, sepsis, insufficient quantity or quality of bone (bone loss greater than 30% of the total articulation or involving an entire column of the distal humerus, coronoid bone loss of 50% or more) and/or soft tissue, material sensitivity, or patients who are unwilling or incapable of following post operative care instructions.The ijs-e system should not be used in pediatric patients or patients with open growth plates." bone loss greater than 30% of the total articulation was identified in the imaging provided violating the contraindication listed above.The procedure performed was an interpositional joint arthroplasty with placement of ijs which is not listed in the indications for use.Per feedback, the physician does not believe the device is at fault.No device problems were identified.Revision procedure was successfully completed and no problems have been identified.
Event or Problem Description
Implant revision 4 weeks post up.

• 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: 10583765
• Report Number: 3006742481-2020-00008
• Device Sequence Number: 16801135
• Product Code: OZI
• UDI-Device Identifier: 00841506104904
• UDI-Public: 00841506104904
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/24/2020

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: 08/25/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 82