MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-09-14 for MEDPOR PLUS SST EZ - 22MM 80062 manufactured by Stryker Craniomaxillofacial Georgia.
[15190710]
The sales representative reported that the surgeon was using the medpor plus sst ez 22mm sphere implant and although the implant fit into the syringe "with a little push," the surgeon had difficulty getting the sphere implant out of the syringe. The sales representative reported that the surgeon used a 15 blade and after working on the syringe for a while, pierce the syringe and was able to peel the syringe open to get the sphere implant out.
Patient Sequence No: 1, Text Type: D, B5
[15722350]
A review of the product history was conducted and there have been no reports of a similar incident to have occurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2011-00029 |
| MDR Report Key | 2308210 |
| Report Source | 05,07 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-09-14 |
| Date of Event | 2011-08-17 |
| Date Mfgr Received | 2011-08-17 |
| Device Manufacturer Date | 2011-05-31 |
| Date Added to Maude | 2012-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFF WILLIAMS |
| Manufacturer Street | 15 DART RD. |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 7702544400 |
| Manufacturer G1 | STRYKER CRANIOMAXILLOFACIAL GEORGIA |
| Manufacturer Street | 15 DART RD. |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR PLUS SST EZ - 22MM |
| Generic Name | IMPLANT |
| Product Code | HPZ |
| Date Received | 2011-09-14 |
| Model Number | NA |
| Catalog Number | 80062 |
| Lot Number | G004828 |
| ID Number | NA |
| Device Expiration Date | 2016-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CRANIOMAXILLOFACIAL GEORGIA |
| Manufacturer Address | NEWNAN GA 30265 US 30265 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-09-14 |