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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BIO-PREP BONE PREPARATION KIT; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO BIO-PREP BONE PREPARATION KIT; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0206710000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: product not available.
 
Event Description
The user facility reported the plastic tool in the cement restrictor set became lodge in the femur during a procedure.After several attempts to remove, the piece broke leaving the end still attached to the restrictor.The decision made was to leave it inside in the patient.There was no medical intervention required.
 
Event Description
The user facility reported the plastic tool in the cement restrictor set became lodge in the femur during a procedure.After several attempts to remove, the piece broke leaving the end still attached to the restrictor.The decision made was to leave it inside in the patient.There was no medical intervention required.
 
Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
 
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Brand Name
BIO-PREP BONE PREPARATION KIT
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
highway #3, km 130.2
kalamazoo MI 49001
MDR Report Key8837180
MDR Text Key152516554
Report Number0001811755-2019-02588
Device Sequence Number1
Product Code JDZ
UDI-Device Identifier34546540039638
UDI-Public34546540039638
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0206710000
Device Lot Number18311012
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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