MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-29 for GRAFTON DBM T43105 manufactured by Osteotech, Inc (subsidiary Of Medtronic).
[4683820]
It was reported that a (b)(6) male patient received allograft bone void filler during a? Left knee arthroscopy with removal of loose ocd (osteochondritis dissecans) lesion; chondroplasty of the patella and trochlea; open anteromedialization tibial tubercle with distalization 8mm (3 x 4. 5 mm low profile cortical screws); bone grafting at tibial tubercle defect site; open excision medial patellar exostosis; open repair patellar sided mpfl (medial patellofemoral ligament) / medial retinaculum. " approximately one month later, the patient returned to the er with pus-like drainage from the incision complaining of feeling feverish, erythema and headache. The patient was admitted to the hospital that same day and underwent an open debridement drainage and irrigation. Patient was started on antibiotics. Two days later, the patient was returned to surgery for incision and drainage. Patient was started on additional antibiotics. Another two days later, the patient was again returned to surgery for incision and drainage. The graft remains in the patient. The patient was discharged from the hospital approximately 5 weeks after his readmission.
Patient Sequence No: 1, Text Type: D, B5
[11815374]
(b)(4). All donor records and manufacturing records relative to the subject graft were reviewed and indicated that the graft was manufactured according to procedure and met all required specifications; all final product sterility and environmental monitoring test results complied. There were no non-conformances associated with the manufacture of the product. The donor records were reviewed by the medical director; the donor was confirmed to have been appropriately screened and tested in accordance with the manufacturer? S donor suitability criteria, and was deemed eligible for transplantation. All infectious disease tests were non-reactive (compliant). The donor tissue underwent low dose pre-processing irradiation with gamma radiation within the required dosage rate. The tissue recovery organization which provided the donor tissue to the manufacturer was notified of this incident, and they have received no additional reports of infection of any type involving any other tissues procured from this donor. The manufacturer has not received any other reports of infection involving any other grafts manufactured from this lot or from this donor tissue. Based on these findings, the medical director has concluded that there is no medical evidence to indicate that the subject graft caused or contributed to the patient's infection, which occurred one month post-op. No further action is required at this time and this event is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2246640-2014-00005 |
| MDR Report Key | 3839463 |
| Report Source | 05,06 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-04-29 |
| Date of Event | 2014-04-25 |
| Date Mfgr Received | 2014-04-29 |
| Device Manufacturer Date | 2013-12-31 |
| Date Added to Maude | 2014-05-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | EDWARD WHEELER |
| Manufacturer Street | 201 INDUSTRIAL WAY WEST |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal | 07724 |
| Manufacturer Phone | 7325422800 |
| Manufacturer G1 | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| 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 | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2014-05-29 |
| Model Number | T43105 |
| Catalog Number | T43105 |
| Device Expiration Date | 2016-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-05-29 |