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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP, 5.5MM, TI; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP, 5.5MM, TI; SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Catalog Number 3301-1
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
It was reported that two pathfinder closure tops stripped during final tightening.Two new closure tops were used to complete the case.There was no delay or impact to the patient.This is report one of two for this event.
 
Manufacturer Narrative
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 report 3012447612-2022-00097.
 
Event Description
It was reported that two pathfinder closure tops stripped during final tightening.Two new closure tops were used to complete the case.There was no delay or impact to the patient.This is report one of two for this event.
 
Manufacturer Narrative
Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no damage to either the screw drives or threads.Root cause: root cause was unable to be determined as no product issue was identified on the returned devices.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.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.
 
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Brand Name
OPEN IMPLANT CLOSURE TOP, 5.5MM, TI
Type of Device
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR 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 Key14073956
MDR Text Key289013516
Report Number3012447612-2022-00096
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024334861
UDI-Public(01)00889024334861(10)87CS
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3301-1
Device Lot Number87CS
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/15/2022
Initial Date FDA Received04/11/2022
Supplement Dates Manufacturer Received07/27/2022
Supplement Dates FDA Received08/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2016
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 SexMale
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