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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SPINE POLYAXIAL PEDICLE SCREW DG 40 INSTINCT JAVA SYSTEM

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ZIMMER SPINE POLYAXIAL PEDICLE SCREW DG 40 INSTINCT JAVA SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Pain (1994)
Event Date 10/19/2016
Event Type  Injury  
Manufacturer Narrative
The returned screw was evaluated. The threaded shaft was found to have fractured; the complaint is confirmed. The evaluation confirmed that the micrographic structure of the material and the hardness are compliant with specifications and there were no particular metallurgical defects found. The root cause is likely attributed to fatigue breakage led by a combination of patient factors and surgical strategy applications.
 
Manufacturer Narrative
Additional information in patient identifier, age or date of birth, weight.
 
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. This is report three of six for this event. Reference report numbers 3003853072-2016-00151 thru 3003853072-2016-00156.
 
Event Description
It was reported that approximately 15 months after installation, the patient presented to the surgeon with pain. X-rays were taken and the surgeon saw signs that the tulip of the pedicle screw at left l-3 detached from the screw shank. It appeared that the pedicle screw at right l-3 was also broken, as well as the rod between the l-3 and l-4 levels. A revision surgery was performed to remove and replace the implants. There were a total of two rods and four pedicle screws removed; it is not yet clear which rod and pedicle screws are broken.
 
Manufacturer Narrative
The device was not returned, so an evaluation could not be performed and no conclusions could be drawn. A review of the manufacturing records did not identify any issues which may have contributed to this event. The labeling was reviewed and found to contain information regarding post-operative expectations.
 
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.
 
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Brand NamePOLYAXIAL PEDICLE SCREW DG 40
Type of DeviceINSTINCT JAVA SYSTEM
Manufacturer (Section D)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer (Section G)
ZIMMER SPINE
23 parvis des chartrons
cite mondiale
bordeaux, cedex 33080
FR 33080
Manufacturer Contact
teresa george
310 interlocken pkwy ste. 120
broomfield, CO 80021
3034437500
MDR Report Key6173309
MDR Text Key117480894
Report Number3003853072-2016-00153
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
PK111301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number046W0AN26540
Device Lot NumberH18766J
Other Device ID Number(01)00889024340275
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2013
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: 12/14/2016 Patient Sequence Number: 1
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