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U.S. Department of Health and Human Services

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

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MEDTRONIC EATONTOWN GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
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.
 
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Brand NameGRAFTON DBM
Type of DeviceBONE GRAFTING MATERIAL, HUMAN SOURCE
Manufacturer (Section D)
MEDTRONIC EATONTOWN
201 industrial way west
eatontown NJ 07724
Manufacturer (Section G)
MEDTRONIC EATONTOWN
201 industrial way west
eatontown NJ 07724
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key11587620
MDR Text Key260550415
Report Number2246640-2021-00001
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
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 Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/04/2019
Device Model NumberT43110INT
Device Catalogue NumberT43110INT
Device Lot NumberA26640-026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/04/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/30/2021 Patient Sequence Number: 1
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