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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problems Screw (568); Break (1069); Disconnection (1171); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2018
Event Type  Malfunction  
Event Description

It was reported that a patient had a procedure on (b)(6) 2016 for adolescent scoliosis correction. Surgery went well, correction obtained with no complication. Screws placed t3-l3. Patient was brought back for surgery (b)(6) 2018 due to l3 left sided screw backed out and potential cause of pain. Surgeon decided to remove all instrumentation as the spine has fused and instrumentation no longer needed. On removing the screws, one of the screws was found broken. This caused no issue to the patient and wasn't the reason for the revision surgery. The patient had a total of 21 screws in originally. One screw had backed out and one screw was broken.

 
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Brand NameUNKNOWN_SPINE_PRODUCT
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 Key7483032
MDR Text Key107463697
Report Number0009617544-2018-00101
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeGB
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 07/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberUNK_SPN
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 Received06/18/2018
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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