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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482802745
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 12/20/2018
Event Type  Injury  
Event Description

It was reported that the screw head came off post-operatively. Per the correspondence with rep, the patient underwent revision surgery on (b)(6) 2018 to replace hardware of bigger size. This will be reported as a serious injury due to medical intervention. The rod was also replaced in revision surgery, however, no issue was reported for the rod.

 
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Brand NameES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR 33610
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8203241
MDR Text Key131642071
Report Number0009617544-2018-00306
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
PMA/PMN NumberK122845
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 03/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number482802745
Device LOT Number189368
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/13/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/28/2018 Patient Sequence Number: 1
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