MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK UNKNOWN MEDTRONIC IMPLANT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Crack (1135)

Patient Problems Neuropathy (1983); Spinal Cord Injury (2432); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device was not returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.

Event Description

It was reported that on an unknown date, post-op, the allograft spacers at levels c5-6, c6-7, and c7-t1 had cracked in situ.During revision surgery , after removing the artificial hardware, the surgeon removed the cracked allograft spacers and the cracked shards of bone from the disc space and replaced each with a peek spacer filled with putty.The old plate was replaced with a new plate and new variable angle self drilling screws were used to lock down the construct.The following patient complications were reported as a result of this event: myelopathy and radiculopathy.Reportedly there were no post-op infection, or immunological or inflammatory response.

• Brand Name: UNKNOWN MEDTRONIC IMPLANT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5158613
• MDR Text Key: 28563318
• Report Number: 1030489-2015-02716
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/22/2015

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• 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): Required Intervention
• Patient Age: 00053 YR