• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SPINE-US 8.5X70 MEDIAL BIASED ANGLE POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 482678570
Device Problem Material Separation (1562)
Patient Problem Injury (2348)
Event Date 05/27/2020
Event Type  Injury  
Manufacturer Narrative
Product return clarification: the screw remains implanted; however, the disengaged tulip head has been returned.
 
Event Description
It was reported that a serrato medial biased polyaxial screw tulip disengaged intra-operatively. During revision surgery, the screw head came off when the final attempt was made to attach the offset connector to the screw. Since the screw body was firmly fixed, it could not be removed and remains in the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name8.5X70 MEDIAL BIASED ANGLE 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
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key10185957
MDR Text Key196155143
Report Number3005525032-2020-00029
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K170496
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 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number482678570
Device Catalogue Number482678570
Device Lot NumberB95660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/23/2020 Patient Sequence Number: 1
-
-