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 2019-03-14 for GRAFTON DBM T44115INT manufactured by Medtronic Eatontown.
[138767949]
Manufacturing assessment review: five manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a36012 and part# t44115. 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. 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
[138767950]
It was reported that the patient underwent scoliosis correction surgery from t6 to s1. Post-op, one month later the implantation of the tissues, the patient suffered due to infection in wound. Patient immune was not compromised and she was not undergoing chemotherapy. Patient went through 24 hour prophylaxis protocol after the initial surgery. The symptoms appeared 10 days after the initial surgery because 10 days later when they were going to remove the stitches, the patient indicated that the wound was open. Patient suffered due to fever as well approx 3 weeks after the initial surgery. Patient underwent revision surgery, where the implants were extracted and a sample have been sent to the laboratory to determine if the infection was caused by the implants. As per the latest update, patient was still in the hospital (icu). Doctors performed another washing of the wound site because the wound was getting infected. At the wound site, doctors found a bacterium called "large negative germ?. Also in the blood culture they found a staphyloco ccus. They did an echocardiogram and it came out negative. The doctor states that it is not certain that the graft is the initial cause of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2019-00002 |
| MDR Report Key | 8419789 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-16 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2019-03-14 |
| 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 | 2019-03-14 |
| 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 | 2019-03-14 |