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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE ST360 FIXED TRANSV. CONNECTOR 5.5X25

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ZIMMER SPINE ST360 FIXED TRANSV. CONNECTOR 5.5X25 Back to Search Results
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2016
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
 
Event Description
The sales associate reported a non-functional crosslink. The doctor thought there was an issue with the crosslink as he could not get one side to engage the rod. The doctor tried to mallet the crosslink onto the rod and it didn't want to seat. The doctor took it off and used a different crosslink of the same size.
 
Manufacturer Narrative
The returned connector was evaluated. There was cosmetic and functional damage which was likely the result of the malleting that was applied to the device during attempted installation by the complainant. The connector was functionally checked using mating components and the event was not able to be replicated; the connector assembled with the rods as expected. A review of the manufacturing records did not identify any issues which would have contributed to this event. The labeling was reviewed and found to contain sufficient instructions regarding proper device usage, including installation and tightening.
 
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Brand NameST360 FIXED TRANSV. CONNECTOR 5.5X25
Type of DeviceCONNECTOR
Manufacturer (Section D)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer (Section G)
ZIMMER SPINE
7375 bush lake road
minneapolis MN 55439
Manufacturer Contact
michelle cole
7375 bush lake road
minneapolis, MN 55439
9528325600
MDR Report Key5871502
MDR Text Key51945495
Report Number0002184052-2016-00155
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK133291
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number07.00401.007
Device Lot Number63072922
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/12/2016 Patient Sequence Number: 1
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