MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-04 for MEDPOR CUSTOMIZED AUGMENTATION 54440610 manufactured by Stryker Orthobiologics-malvern.
[25054370]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device is still implanted in patient.
Patient Sequence No: 1, Text Type: N, H10
[25054371]
Per the company representative, the device was implanted in the patient in (b)(6) 2015. The facility followed up with the company representative to report that the patient acquired an infection at the site of the implant. The hospital is questioning the perosity of the material and whether the implant was exposed to a non-sterile environment; the surgeon has not yet determined whether to treat the infection or perform a revision surgery to remove the implant. As it is currently implanted, the device is not available for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2015-00228 |
| MDR Report Key | 5057665 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-08-06 |
| Date Mfgr Received | 2015-08-06 |
| Date Added to Maude | 2015-09-04 |
| 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 |
| 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 AUGMENTATION |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2015-09-04 |
| Catalog Number | 54440610 |
| Lot Number | K000010047 |
| 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 | 1. Other | 2015-09-04 |