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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE CANNULATED 5.5 POLY SCREW 7.5X45

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ZIMMER SPINE CANNULATED 5.5 POLY SCREW 7.5X45 Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2016
Event Type  Injury  
Manufacturer Narrative
The user facility is foreign; therefore a facility medwatch report will not be available. 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. Report one of four for the same event; see also 0002184052-2016-00076, 00077 and 00078.
 
Event Description
The sales associate reported that a percutaneous screw placement l4-l5 with listhesis gr. 1 - rod insertion 50mm - direction cranial to caudal. Caudal set screw insertion was performed. It is reported the physician was very gentle with the set screw driver, no force was used however the set screw thread broke spontaneously. The physician removed the set screw first, then removed the rod and removed the screw. Another screw was placed using another extender sleeve and the same rod was used to complete the surgery without any further issues.
 
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. Report one of four for the same event, reference 0002184052-2016-00076-1, 00077-1 and 00078-1.
 
Manufacturer Narrative
The returned screw was found to be disassembled; the complaint is confirmed. There are no indications of manufacturing issues which would have contributed to this event. The labeling was reviewed and found to contain instructions regarding implant handling.
 
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Brand NameCANNULATED 5.5 POLY SCREW 7.5X45
Type of DeviceSCREW
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
teresa george
7375 bush lake road
minneapolis, MN 55439
MDR Report Key5707227
MDR Text Key46853884
Report Number0002184052-2016-00075
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
PK132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number3505-7545
Device Lot Number83EA
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2014
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: 06/08/2016 Patient Sequence Number: 1
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