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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 300MM CORD; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
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ZIMMER BIOMET SPINE INC. 300MM CORD; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM Back to Search Results
Catalog Number 204H0300
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
Product code: qhp.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 3012447612-2021-00287 through 3012447612-2021-00300.
 
Event Description
It was reported that a revision surgery was performed to remove a tether construct.The adult patient's curve was not improved as much as was hoped and there appeared to be a loss of correction sometime post-operatively.This is report three of fourteen for this event.
 
Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the two pieces of the cord indicate where 11 screws were tightened into place, but there are no obvious signs of screw sliding or movement along the cord.Dhr review the lot numbers were not provided, so the dhrs could not be reviewed.Potential root cause the cause is attributed to off-label/contraindicated use since this device is approved for use on skeletally immature patients and contraindicated for skeletally mature patients; the patient is an adult.Device usage this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
 
Event Description
It was reported that a revision surgery was performed to remove a tether construct.The adult patient's curve was not improved as much as was hoped and there appeared to be a loss of correction sometime post-operatively.This is report three of fourteen for this event.
 
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Brand Name
300MM CORD
Type of Device
THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key12297484
MDR Text Key265767283
Report Number3012447612-2021-00289
Device Sequence Number1
Product Code QHP
Combination Product (y/n)N
PMA/PMN Number
H190005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number204H0300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Was the Report Sent to FDA? No
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
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