MAUDE Adverse Event Report: CHOICESPINE, LP BLACKHAWK CERVICAL SPACER SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	05-090-22-1405
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) reported that followup xrays showed the anchors were not locked and the implant has backed out.

• Brand Name: BLACKHAWK CERVICAL SPACER SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): CHOICESPINE, LP; 400 erin drive; knoxville TN 37919
• MDR Report Key: 9607076
• Report Number: 3005819474-2018-00001
• Device Sequence Number: 352914
• Product Code: OVE
• UDI-Device Identifier: 00840996164535
• UDI-Public: 00840996164535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 05-090-22-1405
• Device Catalogue Number: 05-090-22-1405
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR