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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. DORSAL HEIGHT AND REVISION TOOL SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

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ZIMMER BIOMET SPINE INC. DORSAL HEIGHT AND REVISION TOOL SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Catalog Number 3367-2
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
The piece of the hex socket at the tip of a dorsal height tool was found broken after surgery. There were no reported surgical impacts.
 
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Brand NameDORSAL HEIGHT AND REVISION TOOL
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
jessica buzbee
10225 westmoor dr.
na
westminster, CO 80021
3038034523
MDR Report Key10895997
MDR Text Key218011033
Report Number3012447612-2020-00676
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024335523
UDI-Public(01)00889024335523(10)61HA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3367-2
Device Lot Number61HA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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