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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 5.5X45MM; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 5.5X45MM; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number 482802545
Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528)
Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)
Event Date 12/18/2015
Event Type  Injury  
Event Description
It was reported that during the es2 removing surgery, the surgeon tried to remove the screw from the patient bone.However, when the surgeon checked the screw, it turned out that the screw shaft was broken.The surgeon could not remove the tip of broken screw from the patient bone.
 
Manufacturer Narrative
Method: complaint history review; risk assessment.Results: the device was not returned and lot number not provided.Conclusion: the plausible root cause of the reported event cannot be determined.
 
Event Description
It was reported that during the es2 removing surgery, the surgeon tried to remove the screw from the patient bone.However, when the surgeon checked the screw, it turned out that the screw shaft was broken.The surgeon could not remove the tip of broken screw from the patient bone.
 
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Brand Name
ES2 INTEGRATED BLADE SCREW SIZE S 5.5X45MM
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 Key5354240
MDR Text Key35450646
Report Number0009617544-2016-00013
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 Physician
Type of Report Initial,Followup
Report Date 12/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number482802545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/18/2015
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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