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 2020-01-21 for GRAFTON DBM T42210JPN manufactured by Medtronic Eatontown.
[176271480]
Other: infection. Manufacturing assessment review: two manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a37921 and part# t42210. Grafton matrix test reports were reviewed ((base sterility, final product sterility, endotoxin, moisture analysis, glycerol content, calcium assay, environmental monitoring). All tests passed and no deviations or non conformances were observed. Donor file <(>&<)> donor eligibility records: donor eligibility documents were reviewed and no non-conformance was found. The donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits. Hcps reviews based on donor charts: in their opinion the infections weren? T caused by tissues as received, processed and distributed by us. 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
[176271481]
It was reported that on (b)(6) 2019, the patient underwent a surgery at l2-s2. The graft was placed on the posterolateral side. On an unknown date, post-op, the patient had infection, which was suspected to be "mrsa". It was suspected that the graft, which was implanted on (b)(6) 2019, was the cause of infection. The patient was re-hospitalized due to this event. Hence, on (b)(6) 2019, approaching from the posterior side, debridement and screw replacement were performed. The graft had been completely explanted in this surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2020-00002 |
| MDR Report Key | 9612398 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-21 |
| Model Number | NA |
| Catalog Number | T42210JPN |
| Lot Number | NA |
| 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 | 2020-01-21 |