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 reported 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: 7019725
• Report Number: 1030489-2017-02310
• Device Sequence Number: 19071620
• 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: 07/30/2023
• Device Catalogue Number: 2150125
• Device Lot Number: 0403865W
• 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