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 Codes	Wound Dehiscence (1154); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Pre-op diagnosis (revision surgery): chronic wound dehiscence, non-union, broken hardware procedure: posterior cervical fusion from occiput to c2.It was reported that on an unknown date, post-op, rod broke.Patient underwent revision surgery for replacement of broken hardware as well as for treatment of non-union and wound dehiscence.Broken rod was replaced.
Additional Manufacturer Narrative
Additional info: product analysis: visual review confirms rod breakage.Damage and smearing noted on fracture surfaces.Optical examination did not identify immediately adjacent pre-existing surface defects that could contribute to crack propagation of fracture.Fracture surface examination of the fractured pin diameter identified ratchet marks on one side near one location of crack origination, with progressive striations or beach marks emanating on opposite sides of the fracture through the cross section of the rods until subsequent mechanical failure near the center line of the pin.Dimensional inspection confirms conformance to print specification.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The above observations are consistent with failure due to cyclic fatigue.
Additional Manufacturer Narrative
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: 6669140
• Report Number: 1030489-2017-01625
• Device Sequence Number: 19092366
• Product Code: KWP
• UDI-Device Identifier: 00613994514509
• UDI-Public: 00613994514509
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 08/15/2017; 08/15/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 08/16/2017; 10/05/2017
• 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: Other; Required Intervention