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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CURVED NEEDLE A LA CARTE; INJECTOR, VERTEBROPLASTY
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STRYKER INSTRUMENTS-KALAMAZOO CURVED NEEDLE A LA CARTE; INJECTOR, VERTEBROPLASTY Back to Search Results
Catalog Number 0306011500
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2015
Event Type  malfunction  
Event Description
It was reported that during a procedure the curved needle broke in half.The surgeon was able to remove it from the cannula.The procedure was completed with an alternate device.There was no impact to the patient.There were no adverse consequences or medical intervention reported.
 
Event Description
It was reported that during a procedure the curved needle broke in half.The surgeon was able to remove it from the cannula.The procedure was completed with an alternate device.There was no impact to the patient.There were no adverse consequences or medical intervention reported.
 
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Brand Name
CURVED NEEDLE A LA CARTE
Type of Device
INJECTOR, VERTEBROPLASTY
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5063559
MDR Text Key25215487
Report Number0001811755-2015-03275
Device Sequence Number1
Product Code OAR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Followup
Report Date 08/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0306011500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/12/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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