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 2019-02-11 for GRAFTON DBM T43110INT manufactured by Osteotech. Inc.
[135704080]
As per the hcp review it was unlikely that the product caused the infection. Manufacturing assessment- the non-conformance database was reviewed and there were no non-conformances found for (b)(4)/t43110int. The donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[135704081]
Procedure: lumbar arthrodesis, laminectomy with decompression, lateral spinal canal scan for foraminotomy bilateral, lumbar disc excision, demineralized bone matrix application in anterior and posterior lumbar spine level implanted: l4-l5/l5-s1 it was reported that post-op, patient had infection on the operating site requiring surgical management and vac implant. Patient currently is in treatment for the infection with antibiotics. Patient was on antibiotics at the time of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2019-00001 |
| MDR Report Key | 8325390 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-25 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2019-02-11 |
| 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 | OSTEOTECH. INC |
| 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 | 2019-02-11 |
| Model Number | NA |
| Catalog Number | T43110INT |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH. INC |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-02-11 |