MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-02-27 for GRAFTON DBM T43105 manufactured by Medtronic Eatontown.
[100999621]
Medical review: as per hcp review, this likely not due to the implanted human tissue, but the allergy tests will be the final determinant. Manufacturing assessment review: manufacturing records (reacting <(>&<)> core packaging routers) for part# t43105, batch# a28701-078 reviewed. There is no deviation observed. Donor file <(>&<)> donor eligibility records: tros confirming all recovery processes for the donors associated with the products from this complaint are compliant, and there were no other reports of adverse reactions involving tissues from these donors. Doctor has reviewed the donor chart and, in his opinion, nothing in the donor record would have caused an untoward event once transplanted. As long as there are no deviations on our end, the adverse event was not caused by donor tissues as received, processed, stored 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
[100999622]
It was reported that the patient underwent transforaminal lumbar interbody fusion (tlif) at l1-l4 due to back and radicular pain. Po st-op, although the patient has done well from a back pain and radicular pain standpoint, she has had hives (an allergic reaction) intermittently since her implantation. Patient does have a latex allergy, but was not knowingly exposed to latex during her surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2018-00003 |
| MDR Report Key | 7298641 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2018-01-30 |
| Device Manufacturer Date | 2017-03-21 |
| Date Added to Maude | 2018-02-27 |
| 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 | 2018-02-27 |
| Model Number | NA |
| Catalog Number | T43105 |
| 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 | 2018-02-27 |