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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 Failure of Implant (1924); Pain (1994); Injury (2348)
Event Date 12/03/2018
Event Type  Injury  
Event Description
It was reported that screw head detached post-operatively. The patient was in pain and underwent revision surgery on (b)(6) 2018. This complaint will be reported as serious injury due to medical intervention.
 
Manufacturer Narrative
Product return information updated.
 
Event Description
It was reported that screw head detached post-operatively. The patient was in pain and underwent revision surgery on (b)(6) 2018. This complaint will be reported as serious injury due to medical intervention.
 
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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 Key8146638
MDR Text Key129782793
Report Number0009617544-2018-00293
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K122845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number482802745
Device Lot Number183975
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2018
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: 12/10/2018 Patient Sequence Number: 1
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