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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TAS 7 DEG LORDOCTIC, IMPLANT STANDARD, 10MM; INTERBODY FUSION DEVICE
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TITAN SPINE, LLC ENDOSKELETON TAS 7 DEG LORDOCTIC, IMPLANT STANDARD, 10MM; INTERBODY FUSION DEVICE Back to Search Results
Catalog Number 2307-0110
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not fully inserted and was removed from the surgical site as a result of the malfunction.The surgical procedure was completed using a 12 deg titan spine implant, which has a smaller posterior ht.The sales rep reported that they were no issues while inserting this device.The patient was not harmed as a result of the malfunction.
 
Event Description
During a alif procedure, a quantity of 2 endoskeleton tas ibd's broke and/or bent during insertion upon impaction.
 
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Brand Name
ENDOSKELETON TAS 7 DEG LORDOCTIC, IMPLANT STANDARD, 10MM
Type of Device
INTERBODY FUSION DEVICE
Manufacturer (Section D)
TITAN SPINE, LLC
6140 w. executive drive
suite a
mequon WI 53092
Manufacturer Contact
jane rodd
6140 w. executive drive
suite a
mequon, WI 53092
2622427801
MDR Report Key7286211
MDR Text Key100780979
Report Number3006340236-2018-00008
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111626
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number2307-0110
Device Lot NumberA130111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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