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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 04/26/2022
Event Type  malfunction  
Event Description
It was reported that three closure tops stripped during final tightening intra-operatively. The closure tops were removed and replaced with alternative closure tops, and another driver was used to complete the procedure without patient impacts. This is report three of three 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 3012447612-2022-00143.
 
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Brand NameOPEN IMPLANT CLOSURE TOP, 5.5MM, TI
Type of DeviceSEQUOIA 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 Key14464010
MDR Text Key292350646
Report Number3012447612-2022-00145
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024334861
UDI-Public(01)00889024334861(10)87QT
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
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3301-1
Device Lot Number87QT
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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