MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for BONUS II-5CC N/A 48-DBM5 manufactured by Zimmer Biomet, Inc..
[88150600]
Reported event was unable to be confirmed due to limited information received from the customer. Review of the dhr found the product was released to distribution with no deviations or anomalies. Review of the complaint history determined that no further action is required as no were trends identified. Current information is insufficient to permit conclusions as to the cause of the events. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88150601]
It was reported that during a clavicle fracture procedure the bonus demineralized bone matrix (dbm) was combined with bone marrow concentrate (bmc), dbm did not soften. The surgeon crushed the dbm and soaked it with the bmc that was left over. The resulting mixture was put into the fracture to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07565 |
| MDR Report Key | 6903605 |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2015-11-12 |
| Date Mfgr Received | 2015-11-12 |
| Device Manufacturer Date | 2014-06-03 |
| Date Added to Maude | 2017-09-29 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONUS II-5CC |
| Generic Name | ALLOGRAFT BONE |
| Product Code | NUN |
| Date Received | 2017-09-29 |
| Model Number | N/A |
| Catalog Number | 48-DBM5 |
| Lot Number | 792060 |
| ID Number | N/A |
| Device Expiration Date | 2017-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-29 |