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)
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis for this procedure: l5/s1 spondylolisthesis, central stenosis it was reported that post-op, the whole construct, including plate, interbody spacer, and screws all migrated to the anterior.Screws were found pulled out.Patient reportedly had back pain and leg pain.Surgeon was identifying options for additional treatment.Patient was unstable and require additional surgery.
Additional Manufacturer Narrative
Additional information: image review- post-op x rays for l5-s1, alif procedure shows anterior displacement of the plate and interbody graft.There appears to be a translational type of anatomy.Contributing factors may include spinal instability which may have required posterior supplementation and improper placement initially.No intra-op films are provided.If information is provided in the future, a supplemental report will be issued.

• 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: 7017687
• Report Number: 1030489-2017-02296
• Device Sequence Number: 11150058
• 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,Followup
• Report Date (Section B): 12/12/2017

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
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/12/2017
• 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: 59 YR