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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET SPINE INC. OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM Back to Search Results
Catalog Number 3301-1
Device Problem Fracture (1260)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
The returned closure top was evaluated. The threads have been removed from the device; however, the damage is not consistent with that of cross-threading since the threads have been completely removed; the thread remnants look like they have been machined concentrically down the length of the closure top. By also reviewing the pedicle screw which was returned with this closure top, it appears that the threads were removed after the closure top was removed from the pedicle screw, and that the threads had cross-threaded. The cause of the initial thread damage is likely related to cross-threading the closure top within the pedicle screw's tulip. However, it is not clear why, how, or when the threads were further altered outside of the tulip. A review of the manufacturing records did not identify any issues which would have contributed to this event.
 
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. 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. (b)(4).
 
Event Description
It was reported that the threads of a closure top were damaged during installation into the mating pedicle screw in surgery. The closure top needed to be cut to be removed and the pedicle screw was also removed. An alternative screw and closure top were used to complete the procedure. There was a surgical delay greater than 30 minutes and the patient retained a device fragment. No further patient impact was reported. This is report one of two for this event.
 
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Brand NameOPEN IMPLANT CLOSURE TOP
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
geoffrey gannon
10225 westmoor dr.
na
westminster, CO 80021
3034437500
MDR Report Key7180354
MDR Text Key108424409
Report Number3012447612-2018-00033
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
PK131980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3301-1
Device Lot Number82CA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/10/2018 Patient Sequence Number: 1
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