MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-16 for MEDPOR CONTAIN SHEET 25MM X 30 81064 manufactured by Stryker Cmf-georgia.
[3338317]
Surgeon removed medpor contain implant from 4 patients due to infection.
Patient Sequence No: 1, Text Type: D, B5
[10627222]
Device not returned for evaluation as it was discarded by the hospital. If additional information is received it will be reported on a supplemental report. (b)(4): device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0008010177-2013-00065 |
| MDR Report Key | 3062037 |
| Report Source | 05 |
| Date Received | 2013-04-16 |
| Date of Report | 2013-03-15 |
| Date of Event | 2013-03-15 |
| Date Mfgr Received | 2013-03-15 |
| Date Added to Maude | 2013-04-17 |
| 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 | MR. JAMSHED BADARPURA |
| Manufacturer Street | MICRO IMPLANTS 750 TRADE CENTRE WAY SUITE 200 |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693245346 |
| Manufacturer G1 | STRYKER CMF-GEORGIA |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR CONTAIN SHEET 25MM X 30 |
| Generic Name | IMPLANT |
| Product Code | NPK |
| Date Received | 2013-04-16 |
| Catalog Number | 81064 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CMF-GEORGIA |
| Manufacturer Address | 15 DART ROAD NEWNAN GA 30265 US 30265 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-16 |