MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for SST EZ SPHERE - 22MM 80014 manufactured by Stryker Orthobiologics-malvern.
[76044412]
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
[76044413]
During the medpor packaging aging remediation (pretest) in the testlab in (b)(4), 1 sst ez sphere showed a particle in pouch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00114 |
| MDR Report Key | 6592251 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-04-27 |
| Date Mfgr Received | 2017-04-27 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2017-05-25 |
| 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 ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SST EZ SPHERE - 22MM |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2017-05-25 |
| Returned To Mfg | 2017-06-19 |
| Catalog Number | 80014 |
| Lot Number | A1610025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |