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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VBT SCREW, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
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ZIMMER BIOMET SPINE INC. VBT SCREW, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM Back to Search Results
Catalog Number 211HXXXX
Device Problem Mechanical Problem (1384)
Patient Problem Spinal Column Injury (2081)
Event Date 08/30/2021
Event Type  Injury  
Event Description
It was reported that a re-operation was performed to address not enough initial correction with tensioning.Removal and replacement of cord and set screws only.Replaced cord and set screws on levels t5 to l2 with new & re-tensioned along the whole construct.The surgeon felt that the new tensioner did not apply as much tension as expected, which contributed to the loss of correction.This is report four of twelve for this event.
 
Manufacturer Narrative
(b)(4).Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2022-00295 through 3012447612-2022-00306.
 
Manufacturer Narrative
Corrections in a1 and b7.Additional information in a2: dob, a4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the product was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to insufficient tension being applied to the cord as a result of unfamiliarity with the instrument.This event could also be the result of patient anatomy or other patient specific factors.Dhr review: the lot numbers were not provided, so the dhrs were unable to be reviewed.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
 
Event Description
It was reported that a re-operation was performed to address not enough initial correction with tensioning.Removal and replacement of cord and set screws only.Replaced cord and set screws on levels t5 to l2 with new & re-tensioned along the whole construct.The surgeon felt that the new tensioner did not apply as much tension as expected, which contributed to the loss of correction.This is report four of twelve for this event.
 
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Brand Name
VBT SCREW, UNKNOWN SIZE
Type of Device
THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key15999947
MDR Text Key305683889
Report Number3012447612-2022-00298
Device Sequence Number1
Product Code QHP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H190005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/23/2023
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? Yes
Device Operator Health Professional
Device Catalogue Number211HXXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/10/2022
Initial Date FDA Received12/16/2022
Supplement Dates Manufacturer Received12/27/2022
Supplement Dates FDA Received01/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age14 YR
Patient SexMale
Patient Weight49 KG
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