MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-30 for MEDPOR CUSTOMIZED-PLUS-L 5444-1-310 manufactured by Stryker Orthobiologics-malvern.
[118868878]
The device is not available for evaluation as it was discarded by the facility at their location due to being a "biohazard". If additional information is received it will be reported in a supplemental report. The product was discarded by the facility at their location due to being a "biohazard".
Patient Sequence No: 1, Text Type: N, H10
[118868879]
It was reported by a company representative that after an initial surgery was completed a revision surgery took place to remove the implant due to an infection. The infection was treated. No additional information is available regarding the infection. Medical intervention and adverse consequences of the revision surgery are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2018-00078 |
| MDR Report Key | 7834272 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-30 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-13 |
| Date Added to Maude | 2018-08-30 |
| 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. GREGORY GOHL |
| 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 | 3 |
| Brand Name | MEDPOR CUSTOMIZED-PLUS-L |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2018-08-30 |
| Catalog Number | 5444-1-310 |
| Lot Number | 1803301006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-30 |