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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT
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STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT Back to Search Results
Model Number 79-45905
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Cerebrospinal Fluid Leakage (1772)
Date of Event 04/07/2021
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.
 
Event or Problem Description
It was reported that it was noticed post-op that there was a cerebrospinal fluid leak at the surgical site.During the revision surgery, it appeared that the fragments of the direct inject seemed to have made a hole in the middle of the duragen (used to close the mater).No other information is known at this time.
 
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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 Key11732449
Report Number0008010177-2021-00022
Device Sequence Number19940232
Product Code GXP
UDI-Device Identifier07613327123265
UDI-Public07613327123265
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K143661
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/27/2021
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? Yes
Operator of Device Health Professional
Device Model Number79-45905
Device Catalogue Number79-45905
Device Lot NumberUNKOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date04/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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