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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 8.5X40MM PEDICLE SCREW SPINAL SYSTEM

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STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 8.5X40MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 482802840
Device Problems Device Issue (2379); Malposition of Device (2616)
Patient Problems Pain (1994); Injury (2348)
Event Date 01/12/2016
Event Type  Injury  
Event Description

It was reported that the patient underwent plif for l4/5/s on (b)(6) 2015. On (b)(6), the patient complaint pain. The surgeon noticed that s1 screw contacted to s1 nerve root and the root cause of pain is the contact. So, revision surgery was performed on same day. S1 screw was removed and new screw was implanted.

 
Manufacturer Narrative

Method: risk assessment. Results: the reported complaint was confirmed by the stryker rep. Manufacturing records could not be reviewed because the explanted devices were discarded and the lot numbers were not provided. Conclusion: the plausible root cause of the reported event is driving the screw too far into the vertebral body as advised against in the stg.

 
Event Description

It was reported that the patient underwent plif for l4/5/s on (b)(6) 2015. On (b)(6), the patient complaint pain. The surgeon noticed that s1 screw contacted to s1 nerve root and the root cause of pain is the contact. So, revision surgery was performed on same day. S1 screw was removed and new screw was implanted.

 
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Brand NameES2 INTEGRATED BLADE SCREW SIZE S 8.5X40MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR 33610
Manufacturer (Section G)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas NJ 33610
FR 33610
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key5413744
MDR Text Key37574417
Report Number0009617544-2016-00047
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 01/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue Number482802840
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 Received01/13/2016
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

Patient TREATMENT DATA
Date Received: 02/05/2016 Patient Sequence Number: 1
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