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

MAUDE Adverse Event Report: SYNTHES (USA) 6.2MM TI CLICK'X® PEDICLE SCR; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

  • 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
 

SYNTHES (USA) 6.2MM TI CLICK'X® PEDICLE SCR; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION Back to Search Results
Catalog Number 498.988
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2014
Event Type  malfunction  
Event Description
It was reported that two pedicle screws broke during insertion.The two pedicle screws both had the same issue.The 3-d polyaxial head broke free from the pedicle screw and the head splayed.The first damaged screw was replaced, and then the second screw encountered the same issue.Both screws were removed and a different pedicle screw system was used.There was a thirty minute delay in the procedure.The broken screws were removed easily with no additional medical intervention.The procedure was completed successfully.This is report 2 of 2 for (b)(4).
 
Manufacturer Narrative
Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
6.2MM TI CLICK'X® PEDICLE SCR
Type of Device
ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key3677378
MDR Text Key4258750
Report Number2520274-2014-10244
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK992739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number498.988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/25/2014
Initial Date FDA Received03/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
-
-