MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN TRANSSPHENOIDAL SELLAR IMPLANT

Catalog Number	82007
Health Effect - Clinical Codes	Hematoma (1884); Meningitis (2389)
Date of Event	02/25/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: TRANSSPHENOIDAL SELLAR IMPLANT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 8659493
• Report Number: 0008010177-2019-00024
• Device Sequence Number: 2663158
• Product Code: FWP
• UDI-Device Identifier: 07613252084716
• UDI-Public: 07613252084716
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 82007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1