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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TITAN MANUFACTURING ENDOSKELETON TL INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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TITAN MANUFACTURING ENDOSKELETON TL INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR Back to Search Results
Model Number 7300-0214-S
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/14/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Information was received from a health care provider via a manufacturer representative regarding a device for degenerative disc disease with olif at l4/5 for spinal therapy.It was reported that revision performed and no malfunction identified.There were no patient symptoms reported.There were no further complications reported regarding the event.
 
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Brand Name
ENDOSKELETON TL INTERBODY SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
Manufacturer (Section D)
TITAN MANUFACTURING
mequon WI 53223
MDR Report Key10917310
Report Number3006340236-2020-00011
Device Sequence Number14131497
Product Code OVD
UDI-Device Identifier00191375031956
UDI-Public00191375031956
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K191581
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/30/2020
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
Operator of Device Health Professional
Device Expiration Date09/21/2024
Device Model Number7300-0214-S
Device Catalogue Number7300-0214-S
Device Lot NumberTM0125175
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/10/2020
Initial Report FDA Received Date11/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age31 YR
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