MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-05-20 for DIRECTINJECT ON DEMAND HA CEMENT 79-45905 manufactured by Stryker Orthopaedics-limerick.
[45587346]
The device has not 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
[45587347]
It was reported during a procedure at the user facility that a piece of plastic from the canula had fractured. There was no surgical delay or adverse consequences with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2016-00104 |
| MDR Report Key | 5669453 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-05-20 |
| Date of Report | 2018-02-12 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-04-26 |
| Device Manufacturer Date | 2016-01-01 |
| Date Added to Maude | 2016-05-20 |
| 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. HANS GEIGER |
| 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 D-79111 |
| Manufacturer Postal Code | D-79111 |
| 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 | 2016-05-20 |
| Catalog Number | 79-45905 |
| Lot Number | DI15357 |
| 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 | 2016-05-20 |