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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 Break (1069); Flaked (1246); Fracture (1260); Use of Device Problem (1670); Malposition of Device (2616); Material Integrity Problem (2978)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2016
Event Type  malfunction  
Event Description
It was reported that; during an c case, doctor attempted to put the self-drilling screws into the cage without pre-drilling/tapping. He did not lock the screws into the cage. An x-ray was taken confirming that neither screw was in the vertebral body and had skived off the endplates. The screws were removed from the cage while the inserter was still attached (meaning he couldn't see the screws to engage the screwdriver), the dr. Then pre-drilled holes and put the same screws back into the cage as they had not been locked in initially. Just before closing the wound, dr. Noticed dark specs of metal within the soft tissues surround the cage which he believes is metal from the c kit. The screw driver, inserter, and hand drill were all checked for damage and all were in good condition. I did take a photo, which does show that the anterior square of the screw, where the screwdriver engages, is damaged and rounded off. This is presumed to have occurred when removing the screws from the cage. Update: 13-sep-2016. Surgeon believes he removed all the pieces, however he wasn't 100%.
 
Manufacturer Narrative
Method: risk assessment; results: device history review, visual inspection and complaint history review was not performed as the lot # is unknown. Conclusion: the possible root cause of this event is not determined as the product was not returned for evaluation.
 
Event Description
It was reported that; during an c case, doctor attempted to put the self-drilling screws into the cage without pre-drilling/tapping. He did not lock the screws into the cage. An x-ray was taken confirming that neither screw was in the vertebral body and had skived off the endplates. The screws were removed from the cage while the inserter was still attached (meaning he couldn't see the screws to engage the screwdriver), the dr. Then pre-drilled holes and put the same screws back into the cage as they had not been locked in initially. Just before closing the wound, dr. Noticed dark specs of metal within the soft tissues surround the cage which he believes is metal from the c kit. The screw driver, inserter, and hand drill were all checked for damage and all were in good condition. I did take a photo, which does show that the anterior square of the screw, where the screwdriver engages, is damaged and rounded off. This is presumed to have occurred when removing the screws from the cage. Update: 13-sep-2016 - surgeon believes he removed all the pieces, however he wasn¿t 100%.
 
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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
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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 Key5993124
MDR Text Key56824598
Report Number3005525032-2016-00120
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAU
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 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6741610
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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