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 2019-04-01 for GRAFTON DBM T44115INT manufactured by Medtronic Eatontown.
[140457079]
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. Manufacturing assessment review: five manufacturing records were reviewed and no related deviations or non conformances were observed for the batch (b)(4) and part# t44115int. Grafton crunch test reports were reviewed (base sterility, sterility, endotoxin, moisture analysis, glycerol content, calcium assay). All tests passed and no deviations or non conformances were observed. Hcp reviews: based on the information provided, doctor don? T believe that the patient? S outcome was not caused by the tissues implanted, as received, processed, packaged , stored and shipped by us. In other words, nothing within the control of mdt, including suitability determination by proxy through our recovery partner, contributed to any events reported from tissues secured and processed from this donor. Donor file & donor eligibility records: the donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits. 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
[140457080]
It was reported that the patient underwent posterolateral spinal surgery due to spinal fracture at t4, t5 and t6, where the patient had been implanted with tissue along with screws from t3 to t7. The patient was in icu for 10 days and after that the patient was transferred to hospitalization. The patient was treated with "fictriazone" and vancomycin 1 gram every 12 hours during he was in icu. On (b)(6) 2019, the patient turned yellow and water started coming out of the injured site. On (b)(6) 2019, the patient underwent revision surgery where the implanted tissue was removed and doctor washed the injured site. There was no necrosis on the walls, there was no pus, there was a granulomatous reaction on the wall and yellowish liquid. The doctor sent a sample of tissue for the culture results and a? Gram negative bacteria? Was found in the result on the wound site. Patient never had fever and also patient? S immune was not compromised and he was not undergoing chemotherapy. The patient recovered few days later and discharged from hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2019-00005 |
| MDR Report Key | 8468481 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-03-02 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2019-04-01 |
| 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 | 2019-04-01 |
| Model Number | NA |
| Catalog Number | T44115INT |
| 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 | 2019-04-01 |