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

Catalog Number	2112355
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Neuropathy (1983); Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient underwent an anterior/posterior reconstruction (bilateral l4-5 anterior/posterior fusion/olif) for grade ii l4-l5 spondylolisthesis and stenosis with interbody cage, bmp and autograft.Following surgery the patient had a significant amount of pain and underwent workup that revealed what appeared to be an acute superior endplate fracture at the level of surgery (l5).A mechanical adverse event of imbalance was noted as anterior subluxation of indwelling interbody device (l4-5 disc space).The patient was to start treatment with ¿forteo¿.At her 6 week post-op visit she was complaining of low back pain and was on dilaudid and was walking with a antalgic gait and ambulating with a walker.Dexa done on (b)(6) 2016 showed mineral densities in the low-normal range with the femoral neck being in the osteopenic range.The patient was also noted to have neuropathy both hands, dilaudid was decreased in strength and dosing at this visit.And patient was continued on bedrest/decreased activity.The outcome of this event is considered not resolved.
Additional Manufacturer Narrative
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: 6112000
• Report Number: 1030489-2016-03183
• Device Sequence Number: 974318
• Product Code: MAX
• UDI-Device Identifier: 00643169605213
• UDI-Public: 00643169605213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2017

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: 12/28/2023
• Device Catalogue Number: 2112355
• Device Lot Number: H5233204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided; 01/17/2017
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 02/10/2017; 09/27/2017
• 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: 55 YR
• Patient Weight: 80