MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-13 for CERAMENT BONE VOID FILLER A0210-08 manufactured by Bonesupport Ab.
| Report Number | 3005304945-2019-00001 |
| MDR Report Key | 9580376 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-13 |
| Date of Report | 2019-09-20 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2020-01-13 |
| 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 | MRS KERSTIN STERNERUP |
| Manufacturer Street | SCHEELEV IDEON SCIENCE PARK |
| Manufacturer City | LUND, 223 70 |
| Manufacturer Country | SW |
| Manufacturer Postal | 223 70 |
| Manufacturer G1 | BONESUPPORT AB |
| Manufacturer Street | SCHEELEV IDEON SCIENCE PARK |
| Manufacturer City | LUND, 223 70 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 223 70 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAMENT BONE VOID FILLER |
| Generic Name | CERAMENT BONE VOID FILLER |
| Product Code | MQV |
| Date Received | 2020-01-13 |
| Model Number | A0210-08 |
| Catalog Number | A0210-08 |
| Lot Number | MLOT0437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BONESUPPORT AB |
| Manufacturer Address | SCHEELEV?GEN 19 IDEON SCIENCE PARK LUND, 22370 SW 22370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-13 |