MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-08 for DIRECTINJECT ON DEMAND HA CEMENT 79-45910 manufactured by Stryker Orthopaedics-limerick.
| Report Number | 0008010177-2020-00002 |
| MDR Report Key | 9565123 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-13 |
| Date Added to Maude | 2020-01-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTINJECT ON DEMAND HA CEMENT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2020-01-08 |
| Catalog Number | 79-45910 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Address | RAHEEN BUSINESS PARK LIMERICK NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |