MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-24 for MEDPOR CUSTOMIZED CRANIAL-L 54440310 manufactured by Stryker Orthobiologics-malvern.
[73492732]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device discarded by or.
Patient Sequence No: 1, Text Type: N, H10
[73492733]
It was reported by the company representative that during a cranial surgery, it was discovered that a new cranial implant was actually a replacement for a medpor cci that was implanted in early 2015. The patient experienced a meningioma which pushed the original medpor cci up, causing the screws to become disengaged from the bone. The tumor was removed, area cleaned, and new implant placed in the patient with no additional adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2017-00088 |
| MDR Report Key | 6515468 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-24 |
| Date of Report | 2018-05-30 |
| Date of Event | 2017-03-28 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2014-12-30 |
| Date Added to Maude | 2017-04-24 |
| 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 | 3 |
| Brand Name | MEDPOR CUSTOMIZED CRANIAL-L |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2017-04-24 |
| Catalog Number | 54440310 |
| Lot Number | K09757KM17MAY |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2017-04-24 |