MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-31 for TRANSSPHENOIDAL SELLAR IMPLANT 82007 manufactured by Stryker Orthobiologics-malvern.
[146689748]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Device likely implanted or discarded by hospital.
Patient Sequence No: 1, Text Type: N, H10
[146689749]
It was noted through a medical publication during a collateral material review that subdural hematoma occurred after the completion of a procedure involving the use of a transsphenoidal sellar implant. The study indicates 1 case of aseptic meningitis. No other information is known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2019-00024 |
| MDR Report Key | 8659493 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2015-02-25 |
| Date Mfgr Received | 2019-05-21 |
| Date Added to Maude | 2019-05-31 |
| 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. RYLEE KOOLE |
| 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 | TRANSSPHENOIDAL SELLAR IMPLANT |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2019-05-31 |
| Catalog Number | 82007 |
| 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 ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |