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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ES2 CANNULATED MODULAR TAP THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US ES2 CANNULATED MODULAR TAP THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 48280145
Device Problems Break (1069); Fracture (1260)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 11/20/2018
Event Type  Injury  
Event Description
It was reported that jamshidi broke intra-op and 40mm of it stuck in the patient pedicle. The pedicle hole was enlarged to remove stuck jamshidi. As per email communication, tap was used and tip of it broken intra-op. Majority of the broken fragments were retrieved. A surgical delay of 2 hours was reported.
 
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Brand NameES2 CANNULATED MODULAR TAP
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 Key8149016
MDR Text Key129875368
Report Number0009617544-2018-00295
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K140400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2019
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 Number48280145
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 Received01/31/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/10/2018 Patient Sequence Number: 1
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