MAUDE Adverse Event Report: MSD DEGGENDORF MFG DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2151116
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post-op, the interbody migrated anteriorly.No future surgery was planned.Patient will be kept under observation.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 7037708
• Report Number: 1030489-2017-02345
• Device Sequence Number: 926798
• Product Code: MAX
• UDI-Device Identifier: 00643169502246
• UDI-Public: 00643169502246
• 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,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: 07/01/2023
• Device Catalogue Number: 2151116
• Device Lot Number: 40AH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017; 11/14/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 11/16/2017; 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