MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	6958716
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent posterior cervical surgery due to cervical vertebra degeneration.Intra-op, the screw was disassembled into 3 parts, nail, nut, and ring.No fragments were remained in the patient body.There were no patient complication reported as a result of this event.The screw was disassembled into 3 parts, nail, nut, and ring.Event date: (b)(6) 2019 date of implant: (b)(6) 2019 date of explant: (b(6) 2019.
Additional Manufacturer Narrative
Product analysis results: visual and optical inspection confirmed the screw has been returned damaged and disassembled into three pieces, the screw head, sleeve and the screw.Macroscopic inspection of the damaged screw head revealed a section had been cut out leaving a uneven very jagged fracture surface.The sleeve had also been damaged the same way.The actual screw was not damaged.The nut of the screw was not returned.It appears the screw was removed by some sort of surgical cutting blade.Unable to determine the root cause of the damaged screw.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 9408037
• Report Number: 1030489-2019-01365
• Device Sequence Number: 2933911
• Product Code: KWP
• UDI-Device Identifier: 00613994355034
• UDI-Public: 00613994355034
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6958716
• Device Lot Number: H5450373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1