MAUDE Adverse Event Report: SKELETAL DYNAMICS INTERNAL JOINT STABILIZER - ELBOW BASE PLATE ASSEMBLY; IJS- ELBOW ASSEMBLY

Model Number	IJS-E Base Plate Assembly
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon identified loose ijs construct 10 days post implantation.
Additional Manufacturer Narrative
No device problems were identified.Revision procedure was completed successfully and no further issues have been identified.The ifu states "if the locking screws or the axis pin is not fully tightened, the construct may loosen, shift, and/or disassemble." as per witness, it was stated that the surgeon did not properly tighten the construct which contributed to malfunction post-implantation.

• Brand Name: INTERNAL JOINT STABILIZER - ELBOW BASE PLATE ASSEMBLY
• Common Device Name: IJS- ELBOW ASSEMBLY
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n kendall drive suite 400; miami FL 33156
• Manufacturer Contact: 7300 n kendall drive; miami, FL 33156
• MDR Report Key: 14091181
• Report Number: 3006742481-2022-00003
• Device Sequence Number: 20281791
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IJS-E Base Plate Assembly
• Device Catalogue Number: IJS-ELB-BPA
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White