MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-08 for OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY 359100 manufactured by Bacterin International, Inc..
[145638880]
A complaint was reported on (b)(6) 2019 indicating that devices containing dbm putty were labeled with a volume of 10. 0cc, however, when the pouches were opened for use, the syringes contained 5. 0cc of dbm putty. The complainant reported that three devices displaying the same defect had been implanted. There were no reported patient complications with this event. The following mdr submissions are related to this event: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025. The complainant returned three additional devices from the same lot number. Upon opening the foil pouch on one device, it was confirmed that the dbm putty was as described by the complainant. The device was labeled as containing 10. 0cc of dbm putty, however, only contained 5. 0cc of dbm putty.
Patient Sequence No: 1, Text Type: N, H10
[145638881]
A complaint was reported on (b)(6) 2019 indicating that devices containing dbm putty were labeled with a volume of 10. 0cc, however, when the pouches were opened for use, the syringes contained 5. 0cc of dbm putty. The complainant reported that three devices displaying the same defect had been implanted. The following mdr submissions are related to this event: 3005031160-2019-00023, 3005031160-2019-00024, 3005031160-2019-00025.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005031160-2019-00023 |
| MDR Report Key | 8592174 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-08 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2018-05-29 |
| Date Added to Maude | 2019-05-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY MING |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal | 59714 |
| Manufacturer Phone | 4063880480 |
| Manufacturer G1 | BACTERIN INTERNATIONAL, INC. |
| Manufacturer Street | 664 CRUISER LANE |
| Manufacturer City | BELGRADE MT 59714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 59714 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
| Generic Name | BONE VOID FILLER |
| Product Code | MBP |
| Date Received | 2019-05-08 |
| Model Number | 359100 |
| Lot Number | B180228-DBM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BACTERIN INTERNATIONAL, INC. |
| Manufacturer Address | 664 CRUISER LANE BELGRADE MT 59714 US 59714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-08 |