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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SCREW+SS 6.0MMX40MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
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ZIMMER BIOMET SPINE INC. SCREW+SS 6.0MMX40MM; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM Back to Search Results
Catalog Number 211H6040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Anemia (1706); Chest Pain (1776); Hemothorax (1896); Pain (1994); Pleural Effusion (2010); Syncope/Fainting (4411); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
Device 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: 3012447612-2020-00544 to 3012447612-2020-00564.
 
Event Description
It was reported that a patient was admitted to the hospital, 2 weeks after undergoing a tether procedure, after presenting with increased pain on his right side.A ct was performed which revealed a hemothorax, a drain was placed with no immediate plans to return to the operating room.The patient was reported to have been discharged from the hospital but no further information was provided.This is report nineteen of twenty-one for this event.
 
Manufacturer Narrative
Correction to g4.Additional information: b5, b6, and h6 (patient codes).
 
Event Description
It was reported that a patient was admitted to the hospital, 2 weeks after undergoing a tether procedure, after presenting with increased pain on his right side.A ct was performed which revealed a hemothorax, a drain was placed with no immediate plans to return to the operating room.The patient was reported to have been discharged from the hospital but no further information was provided.Additional information was provided stating that the patient first presented to the er with shortness of breath, chest pain, and a single syncopal episode.He was released, returned after a clinical visit and was admitted to the hospital where an x-ray showed a large plueral effusion with atelectasis and a significant decrease in hemoglobin.The patient is reported to have been discharged and is in stable condition.This is report nineteen of twenty-one for this event.
 
Manufacturer Narrative
Corrected information in a3, d4: udi number, and h6: impact and clinical codes.Additional information in d4: expiration date, d8, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided, so device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to surgical approach or unknown patient or operational factors.Dhr review: per the dhr review, the part was likely conforming when it left zimmer biomet control.Device use these devices are used for treatment.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.
 
Event Description
It was reported that a patient was admitted to the hospital, 2 weeks after undergoing a tether procedure, after presenting with increased pain on his right side.A ct was performed which revealed a hemothorax, a drain was placed with no immediate plans to return to the operating room.The patient was reported to have been discharged from the hospital but no further information was provided.Additional information was provided stating that the patient first presented to the er with shortness of breath, chest pain, and a single syncopal episode.He was released, returned after a clinical visit and was admitted to the hospital where an x-ray showed a large pleural effusion with atelectasis and a significant decrease in hemoglobin.The patient is reported to have been discharged and is in stable condition.This is report nineteen of twenty-one for this event.
 
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Brand Name
SCREW+SS 6.0MMX40MM
Type of Device
THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key10574111
MDR Text Key208148367
Report Number3012447612-2020-00562
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
Type of Report Initial,Followup,Followup
Report Date 09/15/2021
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
Device Operator Health Professional
Device Catalogue Number211H6040
Device Lot Number3007974
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/23/2020
Supplement Dates Manufacturer Received08/26/2020
09/10/2021
Supplement Dates FDA Received10/29/2020
09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age14 YR
Patient Weight55
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