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
Although it is unknown how many screws migrated, we are filing this report for notification purposes.The mentioned device with quantity as 4 were involved in the event.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
It was reported that post-op, screws migrated anteriorly.No future surgery was planned.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Post-op x ray image provided shows anterior migration of a l5-s1 plate and graft from a alif procedure.This may be a result of instability at the level which may have required posterior supplementation on incorrect surgery/placement initially.No intra-op films are available.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: 7037760
• Report Number: 1030489-2017-02347
• Device Sequence Number: 938945
• Product Code: KWQ
• UDI-Device Identifier: 00643169502406
• UDI-Public: 00643169502406
• 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): 12/13/2017

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: 05/22/2025
• Device Catalogue Number: 2150130
• Device Lot Number: 0566626W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR