• 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 6.5X45 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 6.5X45 POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 482616545
Device Problems Crack (1135); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 10/18/2018
Event Type  Injury  
Event Description
It was reported that upon screw insertion l4 pedicle outer side is cracked. L4 was skipped, construct extended to from l3 to l5. There is no allegation of a device malfunction. The major damage to the bone was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name6.5X45 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
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key8048397
MDR Text Key126505729
Report Number3005525032-2018-00069
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 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number482616545
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 Received12/22/2018
Was Device Evaluated by Manufacturer? No
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: 11/07/2018 Patient Sequence Number: 0
-
-