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

Catalog Number	7752526
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.As per image review the submitted images appear to display complaint product.Unable to identify photographic representation of complaint condition.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: canal stenosis levels implanted: c3-t1 it was reported that intra -op, the head to head crosslink broke during final tightening.The product came in contact with the patient.No fragments remained inside the patient.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Product analysis: the crosslink does not appear to be damaged.The center nut is locked into place and there is no visible signs of damage.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): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6847553
• Report Number: 1030489-2017-02004
• Device Sequence Number: 1600784
• Product Code: KWP
• UDI-Device Identifier: 00613994245472
• UDI-Public: 00613994245472
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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: 7752526
• Device Lot Number: 0515972W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2018
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR