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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES USA 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 498.989
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Sedation (2368)
Event Type  Injury  
Manufacturer Narrative
This device was used for treatment, not diagnosis. Additional narrative: event date: unknown. Additional code: mni, mnh, kwp, kwq. (b)(4). (b)(6). 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient had initial surgery on (b)(6) 2016, operating on levels l3 to l5 with the cick'x system. After the initial surgery, the patient¿s pain continued to persist. On (b)(6) 2016, the surgeon decided to revise the implanted cick'x system by extending the construct. There was a 20-30 minute surgical delay and the patient¿s status is stable. (initial surgery in (b)(4)) this report is 11 of 18 for (b)(4).
 
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Brand Name6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5983978
MDR Text Key55871853
Report Number2520274-2016-14717
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodePE
PMA/PMN Number
K082572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number498.989
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/28/2016 Patient Sequence Number: 1
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