MAUDE Adverse Event Report: GRAFTON DBM; BONE GRAFTING MATERIAL, HUMAN SOURCE

Model Number T43110INT

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

The non-conformance database (qn and roar) were reviewed and there were no reported events for the subject batch.Four manufacturing records were reviewed: 1.Rttis-015 router for medcleaning of donors that will not yield soft tissue 2.Rttis-019 cartridge mill production of fiber for grafton router 3.Rtdbm-019-14 grafton putty reaction router 4.Rtdbm-041-02 putty in jar core packaging router no deviations were identified.Hcp review: after reviewing the complaint and the donor records, i feel confident in stating that the patient¿s complications were not related to our product as received, processed, stored and distributed by medtronic.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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.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 fracture 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 centerpiece 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 (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 spondylodiscitis (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: GRAFTON DBM
• Type of Device: BONE GRAFTING MATERIAL, HUMAN SOURCE
• MDR Report Key: 11587620
• MDR Text Key: 260550415
• Report Number: 2246640-2021-00001
• Device Sequence Number: 1
• Product Code: NUN
• UDI-Device Identifier: 00643169134287
• UDI-Public: 00643169134287
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 03/30/2021

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 Expiration Date: 04/04/2019
• Device Model Number: T43110INT
• Device Catalogue Number: T43110INT
• Device Lot Number: A26640-026
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/04/2016
• 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