MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7755124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not 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 an unspecified surgery.Post-op, the rod broke.It was found in the revision surgery that the left joint connection of the rod was off.The tooth marks in the joints were polished, joint plug had loosened and prolapsed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient underwent occipital and cervical fusion due to skull base depression, the odontoid shift, atlanto-occipital fusion, existence of cervical curvature, along the column could be, vertebral margin and facet joint hyperplasia sclerosis, no obvious narrowing of the intervertebral space, c2 attachment morphological disorders, visible between the lamina on both sides of irregular bone shadow, oppression dural sac, spinal canal narrowing, slight offset in odontoid position, and the distance between the right lateral block proofing narrow.The rod was completely explanted in the revision surgery.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7037680
• Report Number: 1030489-2017-02344
• Device Sequence Number: 16462697
• Product Code: KWP
• UDI-Device Identifier: 00613994514509
• UDI-Public: 00613994514509
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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 Catalogue Number: 7755124
• Device Lot Number: 0523992W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/11/2017
• 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: Required Intervention
• Patient Age: 60 YR