MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	2111250
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
The device 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 patient underwent oblique lumbar interbody fusion (olif) at l3-l4.Post-op, cage has subsided into the endplate.Patient has pain as a result of this event.
Additional Manufacturer Narrative
Additional info: radiology review results: post op ct images for l3-l4 olif procedure showed cage and screws backed off from vertebral bodies.A large inter-body graft was present.There appeared to be a graft and lateral interbody plate present at an adjacent level.It was not clear whether this second level was operated at the same time as the first but the interaction of the plates and added level may contribute to failure of one level.Also, the cage in conjugation with rhbmp-2 may or may not be within the labeled instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIVOX¿ OBLIQUE LATERAL SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6947229
• Report Number: 1030489-2017-02191
• Device Sequence Number: 16429354
• Product Code: MAX
• UDI-Device Identifier: 00643169601468
• UDI-Public: 00643169601468
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 12/24/2023
• Device Catalogue Number: 2111250
• Device Lot Number: H5232064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/09/2017
• 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: 54 YR