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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; PEDICLE SCREW SPINAL SYSTEM
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STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Catalog Number UNK_SPN
Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2017
Event Type  Injury  
Event Description
It was reported that; i received a call today from sales rep, indicating that a patient is looking for compensation for a revision surgery he had involving a set screw back out.It was communicated that this patient had a previous revision surgery due to a screw back out and is now scheduled for an additional revision surgery due to a screw back out on (b)(6) 2017.
 
Manufacturer Narrative
Date of implant: (b)(6) 2017.Method: risk assessment; result: device history review could not be performed as the reported device was not properly identified.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as the reported device was not properly identified.Conclusion: the root cause of the reported event could not be determined because no device and/or insufficient information was provided for review.
 
Event Description
It was reported that; i received a call today from sales rep, indicating that a patient is looking for compensation for a revision surgery he had involving a set screw back out.It was communicated that this patient had a previous revision surgery due to a screw back out and is now scheduled for an additional revision surgery due to a screw back out on (b)(6) 2017.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
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 Key6713933
MDR Text Key80049419
Report Number0009617544-2017-00282
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeUS
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 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2017
Is this an Adverse Event Report? Yes
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
Date Manufacturer Received06/20/2017
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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