MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT

Catalog Number 79-45910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation as it was discarded by the hospital.If additional information is received it will be reported on a supplemental report.

Event Description

Customer had a craniotomy and had to get a revision surgery due to a csf leak.Customer said there is not a direct product complaint.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 8684748
• MDR Text Key: 147563233
• Report Number: 0008010177-2019-00032
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 07613327123272
• UDI-Public: 07613327123272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 79-45910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other