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

Catalog Number	7002527
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2019
Type of Reportable Event	Malfunction
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 posterior cervical fusion due to cervical degeneration and spondylosis.Intra-op, the crosslink broke.The crosslink was completely explanted after it broke, with no broken fragments of the product remaining in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the crosslink eyebolt of the crosslink has been broken.One setscrew remained threaded into the crosslink arm and the other was not returned.Microscopic inspection of the eyebolt fracture revealed a fairly flat surface with slight circular material flow.It appears the nut of the crosslink was overtightened causing the eyebolt portion to break off while the threaded portion remained inside the nut.This type of damage is consistent with torsional overload.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: 9368365
• Report Number: 1030489-2019-01334
• Device Sequence Number: 14187085
• Product Code: KWP
• UDI-Device Identifier: 00885074175065
• UDI-Public: 00885074175065
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 7002527
• Device Lot Number: 0090459W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 10/27/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR