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

Catalog Number	2150130
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that during a follow up visit after three months of the operation, surgeon observed that the plate had pulled away from the sacral body.Screws were pulled out of the bone and are still retained in the plate.However, the patient is clinically doing very well and so at this time, no further action will be taken.
Additional Manufacturer Narrative
Additional information: (x-ray image review): image review: "post op x-rays for l5-s1 anterior lumbar interbody fusion show grade ii spondylolisthesis and anterior displacement of l5-s1 cage.We don't have intra-op films to see if this was placed correctly to begin with,but given significant spondylolisthesis suspect that reduction had not occurred at the time of surgery.Given spinal instability and history of parkinson, posterior augmentation may have been appropriate." if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6553374
• Report Number: 1030489-2017-01150
• Device Sequence Number: 18989429
• Product Code: KWQ
• UDI-Device Identifier: 00643169502406
• UDI-Public: 00643169502406
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K150135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2017

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 Expiration Date: 07/21/2023
• Device Catalogue Number: 2150130
• Device Lot Number: 0398801W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 06/13/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 07/06/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR