MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-21 for OSTEOSELECT 359100 manufactured by Bacterin International, Inc..
[70765523]
The company was notified on 02/24/2017 that an expired product was implanted into a patient on (b)(6) 2017. The product's expiration date was 02/08/2017. The hospital was notified by the company on 02/20/2017 that they had an expired graft in inventory. Subsequent communication with the hospital on 03/10/2017, revealed that an employee absence could have contributed to the incident despite the notification from the company. Patient discharged on (b)(6) 2017 with no known complications. Device implanted, not returned for eval.
Patient Sequence No: 1, Text Type: N, H10
[70765524]
The company was notified on 02/24/2017 that an expired product was implanted into a patient on (b)(6) 2017. The product's expiration date was 02/08/2017. The hospital was notified by the company on 02/20/2017 that they had an expired graft in inventory. Subsequent communication with the hospital on 03/10/2017, revealed that an employee absence could have contributed to the incident despite the notification from the company. Patient discharged on (b)(6) 2017 with no known complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168462-2017-00001 |
| MDR Report Key | 6421696 |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-20 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-02-24 |
| Device Manufacturer Date | 2014-12-05 |
| Date Added to Maude | 2017-03-21 |
| 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 | OSTEOSELECT |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2017-03-21 |
| Model Number | 359100 |
| Lot Number | B110246-DBM |
| Device Expiration Date | 2017-02-08 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 2 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 | 2017-03-21 |