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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, PEDICLE SPINAL FIXATION

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SYNTHES USA; ORTHOSIS, PEDICLE SPINAL FIXATION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: additional patient information: patient height reported as 5 feet 11 inches.Date of onset for the patient¿s post-operative pain is unknown.This report is for one (1) unknown click¿x system.The system was extended, not explanted, during the revision procedure on (b)(6) 2015.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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.
 
Event Description
It was reported that a patient underwent a posterior fusion procedure on (b)(6) 2007 during which a click'x system was inserted from l5 to s1.On (b)(6) 2015, the construct was extended to l4 due to lower back and bilateral leg pain.The symptoms reportedly resolved after surgery.No additional information was available.This report is for one (1) unknown click'x system.This report is 1 of 1 for (b)(4).
 
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Type of Device
ORTHOSIS, PEDICLE SPINAL FIXATION
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5162824
MDR Text Key28813337
Report Number2520274-2015-16747
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Report Date 10/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight91
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