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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 03821540
Device Problems Break (1069); Detachment Of Device Component (1104); Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2018
Event Type  malfunction  
Event Description
It was reported that the tulip/ blades broke off the screw thread after final tightening. A new screw was used to complete the procedure. There was a total surgical delay of 20 to 30 minutes. There were no adverse health consequences to the patient.
 
Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment. Result: the customer reported event was confirmed via visual inspection. The device was returned in 2 pieces, with the tulip head disengaged from the screw shank. There was still a blocker threaded into the es2 screw blades. Deformation was found on the tulip locking ring and on the screw shank head. Manufacturing history was reviewed and no issues were identified. Conclusion: according to risk file, too much stress on the construct may cause stress concentration resulting in the failure of screw tab intra op. Root cause of the reported event could not be determined conclusively but potentially could be due to: user error, blocker not correctly aligned in tulip threads, too much torque applied (in excess of 12nm), counter torque tube not used, cantilever force applied during final tightening, rod seated poorly in tulip.
 
Event Description
It was reported that the tulip/ blades broke off the screw thread after final tightening. A new screw was used to complete the procedure. There was a total surgical delay of 20 to 30 minutes. There were no adverse health consequences to the patient.
 
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Brand NameES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7395061
MDR Text Key104547925
Report Number0009617544-2018-00075
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04546540149176
UDI-Public(01)04546540149176
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03821540
Device Catalogue Number482804740
Device Lot Number177356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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