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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 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number 482802645
Device Problems Break (1069); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 03/28/2017
Event Type  malfunction  
Event Description
It was reported that; the extraction surgery was performed due to healing of the disease.During the extraction surgery, the breakage of l5 right side screw was found.The tip of the screw was remained to the patient and the surgery was finished.
 
Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The returned screw was inspected and it was confirmed to be fractured.Conclusion: the plausible root cause of the event is high activity of the patient leading to stress on the implant causing fracture.
 
Event Description
It was reported that; the extraction surgery was performed due to healing of the disease.During the extraction surgery, the breakage of l5 right side screw was found.The tip of the screw was remained to the patient and the surgery was finished.
 
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Brand Name
ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
Type of Device
PEDICLE 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 33610
FR   33610
Manufacturer Contact
rakshya bista
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6518666
MDR Text Key73899732
Report Number0009617544-2017-00167
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327001945
UDI-Public(01)07613327001945
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number482802645
Device Catalogue Number482802645
Device Lot Number153180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/24/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age63 YR
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