MAUDE Adverse Event Report: WARSAW ORTHOPEDICS DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	2150125
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/13/2017
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 r eported event.X-ray review results: post-op x-ray for l5-s1 alif shows migration of plate and screws.Spondylolisthesis appears usual.Pre-op film demonstrating the deformity and intra-op films showing initial placement which would be helpful.Suspect degree of deformity and instability at this level contributed to constant films.
Event or Problem Description
It was reported that, post-op, entire construct migrated forward and screws pulled out.Ongoing leg pain and back pain was reported.No surgery is currently scheduled.

• Brand Name: DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7019712
• Report Number: 1030489-2017-02311
• Device Sequence Number: 16524686
• Product Code: KWQ
• UDI-Device Identifier: 00643169502390
• UDI-Public: 00643169502390
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K150135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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 Expiration Date: 03/23/2025
• Device Catalogue Number: 2150125
• Device Lot Number: 0553402W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• 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
• Patient Age: 56 YR