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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 10MM PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 10MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 6741610
Device Problems Fracture (1260); Difficult to Insert (1316); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2017
Event Type  malfunction  
Event Description
It was reported that; attempted to fix the screw by flexible driver, but difficult to fix, so could not insert the screw. Finally, removed it out of patient's body. Replaced inserter and attempted to fix the screw again. But the clip popped out.
 
Manufacturer Narrative
Visual inspection; material analysis; device history review; complaint history review; risk assessment. A material analysis (mar) was performed on the returned device and concluded that the fracture surface exhibited a mode consistent with ductile overload. No material or manufacturing defects were found. The plausible root cause of the reported event cannot be determine conclusively due to insufficient information provided regarding the event.
 
Event Description
It was reported that; attempted to fix the screw of by flexible driver, but difficult to fix, so could not insert the screw finally. Remove it out of patient body. Replaced inserter to and attempted to fix the screw again. But the clip in popped out.
 
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Brand NameANCHOR C DIAM 3.5MM SELF DRILLING 10MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH 2300
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH 2300
Manufacturer Contact
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6404305
MDR Text Key70302230
Report Number3005525032-2017-00023
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6741610
Device Lot NumberBWH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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