MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number 7510200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Although it is unknown which of the devices caused or contributed to the event, we are fling this report for notification pu rposes.Following devices were involved: part# lot# qty 510k/ pma# upn (b)(4) unk 1 p000058 00681490843782 779170005 unk 1 k101074 00613994739438 779145555 unk 1 k101074 00613994739414 1475501080 unk 1 k113174 00613994792679 54840005550 unk 1 k091974 00613994589736 5440030 unk 1 k102555 00613994790705.Neither the device nor films of applicable imaging studies were 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 Description

It was reported that post op, the patient had extreme pain with the movement of arms and body, muscle spasms and cramps.Lower lumbar pain constantly, dull aches when she sits and when she stands up pressure is so great.She had pain down left leg sciatic nerve, thighs lock up from severe pain.

Event Description

Patient demographics: initials: (b)(6); gender: female; age: (b)(6) years, implant date: (b)(6) 2015.It was reported that on unknown date, post-op, the patient had extreme pain with the movement of arms and body, muscle spasms and cramps.Lower lumbar pain constantly, dull aches when she sits and when she stands up pressure is so great.She has pain down left leg sciatic nerve, thighs lock up from severe pain.(b)(6) 2021, email: additional information received states that the rod was broken at the spine.It caused injury that was repaired, and the surgery allegedly left many unattached screws in the patient's body that keeps the lower back weak.The patient was in so much pain that in (b)(6) 2016, the surgeon said that we had to remove the product.The surgeon showed the patient the mri of the lumbar spine and explained the same in detail.The patient was asked to come back in april to set a date for surgery.On (b)(6) 2018, the patient found out that the implant rod securing the lumbar spine had allegedly broken.On (b)(6) 2018, a piece of bone was allegedly removed when the spine was severed and an infuse was implanted into the spine.The hcp made an appointment in 2011 for a spinal stenosis diagnosis.This resulted in surgery on (b)(6) 2011, and several weeks later, a lumbar disk ruptured, requiring another surgery on (b)(6) 2011, to replace disk.The fusion was scheduled for (b)(6) 2015.Primary diagnosis: stenosis of lateral recess of lumbar spine.Patient surgical history: lumbar laminectomy (2011).Lumbar fusion ((b)(6) 2015) patient came for a follow up visit on (b)(6) 2018, the patient describes diffuse axial back pain throughout her lower lumbar spine.Her symptoms generally worsened with physical activity.The patient also reported bilateral leg pain, she described radiating pain in her sciatic region.Ct scan of lumbar spine demonstrate what appears to be fractured instrumentation at l2-3 where there is some sort of construct connection.There is a presumed nonunion at l1-2 and l2-3.There is an apparent solid bony union and l2-3 and l3-4.Mri of lumbar spine demonstrate lateral recess stenosis at l2-3 and degenerative changes consistent with nonunion at this level.There are advanced degenerative changes at l5-s1.Assessment: complex patient with advanced degenerative changes and instrumentation failure with a pseudarthrosis.Plan: revision thoracolumbar fusion with removal of previous instrumentation, left sided transforaminal lumbar interbody fusion l2-3 possible l1-2 thoracolumbar fusion t11-s1 right sided transforaminal lumbar interbody fusion l5-s1 specially with the use of infuse bone graft and other level and procedures as indicated.

Manufacturer Narrative

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

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 7166988
• MDR Text Key: 96444072
• Report Number: 1030489-2018-00016
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 7510200
• Device Catalogue Number: 7510200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female