MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-02-05 for GRAFTON DBM T42308INT manufactured by Medtronic Eatontown.
[98996686]
Medical review: per hcp review, "such a transmission from reported tissues, as processed and handled by manufacturer is impossible. " manufacturing assessment review: the non-conformance database was reviewed and there were no non-conformances found for serial# (b)(4), part# t42308int related t o the complaint. Also, manufacturing records were reviewed (reacting router, core packaging router)for the grafton matrix plug batch (b)(4), product code t42308-ifp and no deviations were found. The device was not 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
[98996687]
The patient underwent dental surgery in which the bone graft was used. It was reported that post-operatively, the patient complained of having herpes 1 and 2 virus. The surgeon is unsure if the cause of the disease is the graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2018-00001 |
| MDR Report Key | 7240885 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-02-05 |
| Date of Report | 2018-03-03 |
| Date Mfgr Received | 2018-02-05 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2018-02-05 |
| 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 | 2018-02-05 |
| Model Number | NA |
| Catalog Number | T42308INT |
| Lot Number | NA |
| Device Expiration Date | 2019-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-02-05 |