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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 6.5MMX45MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
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ZIMMER BIOMET SPINE INC. SCREW+SS 6.5MMX45MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM Back to Search Results
Catalog Number 211H6545
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 fourteen of fourteen for this event.
 
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 fourteen of fourteen for this event.
 
Manufacturer Narrative
Inspection: the set screws and screws show evidence and minor damage to the threads that are indicative of use.Additionally, there is damage to the thread lead on one set screw that appears to be indicative of collision with another object, possibly during the removal process or subsequent cleaning, that prevents it from threading completely down into the tulip of the screw.There is no damage or wear that would point to a specific failure mode in-vivo.Dhr review: the lot number was not provided, so the dhr 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.
 
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Brand Name
SCREW+SS 6.5MMX45MM
Type of Device
THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key12297523
MDR Text Key265763274
Report Number3012447612-2021-00300
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 Number211H6545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/25/2021
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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