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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482619590
Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2019
Event Type  malfunction  
Manufacturer Narrative
An urgent medical device recall letter was sent on 01 july 2019 to the affected customers. The urgent medical device recall letter was sent to notify customers that the affected product has been voluntarily recalled by stryker and has already been removed from their inventory by the local representative.
 
Event Description
A screw labelled as 95 mm, was actually 100 mm in length. No patient involvement or adverse consequences to a patient.
 
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Brand Name9.5X90 POLYAXIAL SCREW
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-SWITZERLAND
le crêt-du-locle 10 a
-
la chaux-de-fonds 2300
CH 2300
Manufacturer Contact
margarita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8778453
MDR Text Key150702275
Report Number3005525032-2019-00070
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07613327351576
UDI-Public07613327351576
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number482619590
Device Lot NumberB88751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2019
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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