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

Model Number	79-45905
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2021
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 not available for return.
Event or Problem Description
It was reported that the directinject was injected into the surgical sight and it was noticed during a post-op scan, that a white foreign substance flowed into the dura.There is no further information known at this time.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• MDR Report Key: 11405049
• Report Number: 0008010177-2021-00017
• Device Sequence Number: 4760200
• Product Code: GXP
• UDI-Device Identifier: 07613327123265
• UDI-Public: 07613327123265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: No Information
• Device Model Number: 79-45905
• Device Catalogue Number: 79-45905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other