MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-14 for DBM PUTTY 5.0CC, AXOGRAFT X090-0015-PT5CC manufactured by Bacterin International, Inc..
[86515552]
The patient condition was again verified on 09/11/2017 (date of this report) and no complications were reported.
Patient Sequence No: 1, Text Type: N, H10
[86515553]
On (b)(4) 2017 bacterin was notified of an expired dbm putty graft implant. The graft was sold and distributed to a private label distributor on 11/02/2015. The private label distributor shipped the graft to the end-user facility on 11/23/2015. The graft expired on 12/03/2016, and then was implanted on (b)(6) 2017. At the time of this report there were no known complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168462-2017-00002 |
| MDR Report Key | 6866780 |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-11 |
| Date of Event | 2017-08-17 |
| Date Facility Aware | 2017-08-17 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 2013-11-21 |
| Date Added to Maude | 2017-09-14 |
| 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 | MR. CASEY MING |
| Manufacturer Street | 600 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer Phone | 4063880480 |
| Manufacturer G1 | BACTERIN INTERNATIONAL, INC. |
| Manufacturer Street | 600 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DBM PUTTY 5.0CC, AXOGRAFT |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2017-09-14 |
| Model Number | X090-0015-PT5CC |
| Lot Number | B110137-DBM |
| Device Expiration Date | 2016-12-03 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BACTERIN INTERNATIONAL, INC. |
| Manufacturer Address | 600 CRUISER LANE BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |