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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 HEX STRAIGHT ROD 5.5 X 80MM UNKNOWN SPINE PRODUCT

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STRYKER SPINE-FRANCE ES2 HEX STRAIGHT ROD 5.5 X 80MM UNKNOWN SPINE PRODUCT Back to Search Results
Catalog Number 482807080
Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Material Integrity Problem (2978)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 11/25/2016
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2015 4 screws were implanted for l1 right without problem. On (b)(6) 2016 attempted to remove after fused bones of the spine by plan, but a screw had been separated, so couldn't remove it out of patient body. Other 3 screws have been completed to remove.
 
Manufacturer Narrative
Risk assessment; the implants were implanted for 15 months. Product was not returned and lot# was not provided. The plausible root cause of this event is likely to be fatigue due to the length of implantation.
 
Event Description
It was reported that on (b)(6) 2015 4 screws were implanted for l1 right without problem. On (b)(6) 2016 attempted to remove after fused bones of the spine by plan, but a screw had been separated, so couldn't remove it out of patient body. Other 3 screws have been completed to remove.
 
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Brand NameES2 HEX STRAIGHT ROD 5.5 X 80MM
Type of DeviceUNKNOWN SPINE PRODUCT
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
christa marrow
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6190944
MDR Text Key63313124
Report Number0009617544-2016-00498
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
Type of Report Initial,Followup
Report Date 02/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number482807080
Device Lot NumberL9N
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 Received11/25/2016
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

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