MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-02 for GRAFTON DBM T43105JPN manufactured by Medtronic Eatontown.
[188485939]
Outcomes to adverse event: infection. Manufacturing assessment results: two manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a39430 and part t43105jpn. Grafton putty test reports were reviewed (final product sterility, endotoxin, moisture analysis, glycerol content, calcium assay, environmental monitoring). All tests passed. Hcp reviews: as per hcp opinion the infection was not caused by the grafton putty as received, processed and distributed by medtronic. Also hcp reviewed the donor chart, and he did not believed that our product caused the patient? S infection. Donor file & donor eligibility records: the donor charts revealed no additional reports of adverse reactions involving any other organs/tissues recovered from this donor. Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination. There were no deviations from established procedures that may have increased the risk of contamination/cross contamination. All supplies and reagents used during the recovery were in compliance with 21cfr1271. 210. The recovery was performed within the established time and temperature limits for recovery. 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.
Patient Sequence No: 1, Text Type: N, H10
[188485940]
It was reported that the patient underwent posterior cervical fixation at c2-t1 due to cervical spondylosis and the unilateral open-door laminoplasty were performed. In the surgery, 5cc of tissue has been implanted in the patient. Post-op, the patient had infection on same level. Patient underwent revision surgery as a result of this event and the tissue was removed from the infected site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2020-00001 |
| MDR Report Key | 9537273 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-01 |
| Date Mfgr Received | 2019-12-03 |
| Device Manufacturer Date | 2019-04-16 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC EATONTOWN |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM |
| Generic Name | BONE GRAFTING MATERIAL, HUMAN SOURCE |
| Product Code | NUN |
| Date Received | 2020-01-02 |
| Model Number | NA |
| Catalog Number | T43105JPN |
| Lot Number | A39430-020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC EATONTOWN |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-02 |