MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 9391928

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Spinal Column Injury (2081); Spinal Cord Injury (2432); Paraplegia (2448)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

Hcp review - medical safety assesses the reported event of post-surgical patient complications, including 2 events of rash/skin redness and fever as not likely related to the device because of the following explanations: the first event (tto of 10 days) was resolved after antibiotic treatment without device removal, and it can be caused by general surgery known complications; and the second event had tto of about 3 years post-op, no elevated nickel-chrome levels in the blood, and no inflammation at the implant area suggesting an unlikely relationship.Additionally, it is important to note that this case has some limitations regarding a lack of information on the patient¿s medical history and concomitant medications.If information is provided in the future, a supplemental report will be issued.

Event Description

The information was received from regulatory agencies regarding a patient with facture for olif spinal fusion therapy at l2-l4.It was reported that on (b)(6) 2016, a young woman sustained a severe lwk 3 fracture with high-grade injury of the spinal canal as well as lesion of the nerve sac (dural sac) and the root knee l3 on the left with incomplete paraplegia.She was subsequently repatriated in an emergency and hospitalised at the university hospital (b)(6), where a decompression and laminectomy of l2 to 3 as well as a straightening of the vertebral body and suturing of the torn dura were performed in an emergency.The vertebral body was so destroyed that it had to be replaced.The patient was implanted with a t2-altitude centrepiece 19x28mm 19c (procedure: olif left l2-l4) and a 2x4° top and bottom endplate on (b)(6) 2016 at the university hospital (b)(6).In addition, demineralised bone matrix with autologous cancellous bone was created.The bone matrix is a commercial demineralised bone matrix.Autologous bone was also harvested from the patient and reimplanted.Since the implantation, the patient has repeatedly experienced various health problems.In the meantime, a nickel allergy is suspected as the cause.On (b)(6) 2016, the patient developed fever and had elevated inflammation values (crp 200), which is why antibiotic therapy was started.There was also redness of the skin of the cheek.Approximately 10 days after the operation, a rash appeared on the upper back.This was examined by the dermatology and infectious diseases department.Subsequently, the inflammation values improved again.In (b)(6) 2019, the patient was readmitted to the university hospital of (b)(6) because she had recurrent fevers of up to 39°c.It was clarified whether the patient had developed a rash on her upper back.It was clarified whether a spondylodisitis (inflammation of the vertebral bodies) had possibly developed or whether a material infection was present.However, the subsequent examinations showed that there was no infection in the area of the implant (spect ct of (b)(6) 2020 and mri of (b)(6) 2019 as well as repeated laboratory tests show no evidence of an infection.No elevated nickel-chrome levels in the blood).There was no further complication reported.

• Brand Name: T2 SPINAL SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11587609
• MDR Text Key: 243066466
• Report Number: 1030489-2021-00419
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K100976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9391928
• Device Catalogue Number: 9391928
• Device Lot Number: VNY2Q022-AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• 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): Hospitalization; Other