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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CONTACT FUSION CAGE W/8 H9 TAV; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR

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SYNTHES GMBH CONTACT FUSION CAGE W/8 H9 TAV; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR Back to Search Results
Catalog Number 495.009VS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient expected to undergo a revision surgery for treating thoracic myelopathy.The patient underwent for the primary procedure to treat possible spinal canal stenosis in (b)(6) 2013.No further information is available.This complaint involves twenty (20) devices.This report is for (1) ti contact fusion cage 9mm width/11mm height.This report is 4 of 20 for (b)(4).
 
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Brand Name
CONTACT FUSION CAGE W/8 H9 TAV
Type of Device
INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ   4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12205122
MDR Text Key262908764
Report Number8030965-2021-05959
Device Sequence Number1
Product Code OVD
UDI-Device Identifier07611819293816
UDI-Public(01)07611819293816
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/22/2021
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
Device Catalogue Number495.009VS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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