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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bone Fracture(s) (1870); Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Type of Device: 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
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6112000
• MDR Text Key: 60280859
• Report Number: 1030489-2016-03183
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169605213
• UDI-Public: 00643169605213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: 2112355
• Device Lot Number: H5233204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 80