MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for DIRECTINJECT ON DEMAND HA CEMENT 79-45910 manufactured by Stryker Orthopaedics-limerick.
[102206744]
The device has not yet been received at the manufacturer for testing. An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[102206745]
It was reported that during a procedure, the syringe tip on the 10cc direct inject broke at the base, and the cement came out from there. There were no adverse effects to the patient. The surgeon opened another direct inject and the case was completed successfully. No significant delay or medical intervention reported was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00026 |
| MDR Report Key | 7327455 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-03-09 |
| 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 | 0 |
| Brand Name | DIRECTINJECT ON DEMAND HA CEMENT |
| Generic Name | IMPLANT |
| Product Code | GXP |
| Date Received | 2018-03-09 |
| Catalog Number | 79-45910 |
| Lot Number | DI17289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-09 |