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Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted. The warnings in the package insert state this type of event can occur. 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 three of six for the same event, reference 3003853072-2016-00060 through -00064 and 0002184052-2016-00094.
Event Description
Since (b)(6) 2015, the patient had begun experiencing increasing low back pain. On (b)(6) 2016, it is noted in an office note that there is evidence of a broken screw. No specific occurrences (e. G. Trauma, non-compliance) are related to this occurring. The patient's bone quality and current status/condition was not indicated. It is reported fusion did not occur. No x-rays or surgical report are available at this time. Indication of the initial surgery degenerative disc at lumbar 4-5, 5-sacral 1 with spondylolisthesis. Description of the construct implanted during the initial surgery. Lumbar 4-5-sacral 1 pedicle screws with cross connector.
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. Two lots were returned that were not reported, therefore initial reports 3003853072-2016-00103 and 3003853072-2016-00104 were submitted. Supplemental report three of five 3003853072-2016-00060-1 through 3003853072-2016-00064-1.
Manufacturer Narrative
The investigation was completed with the returned construct parts and the information available. A review of the manufacturing records did not find any issues which would have contributed to this event. The root cause of this event cannot be conclusively determined, however, as the hardness and micrographic structure were tested and shown to be perfectly consistent with (b)(4), it is likely that the device broke following a phenomenon of progressive cracking attributable to repeated cyclic flexion.
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Type of DeviceBLOCKER
Manufacturer (Section D)
23 parvis des chartrons
cite mondiale
bordeaux 33080
FR 33080
Manufacturer (Section G)
23 parvis des chartrons
cite mondiale
bordeaux 33080
FR 33080
Manufacturer Contact
michelle cole
1520 tradeport drive
jacksonville, FL 32218
MDR Report Key5742848
MDR Text Key47971792
Report Number3003853072-2016-00062
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number046W0AN00002
Device Lot NumberE83355
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2015
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: 06/22/2016 Patient Sequence Number: 1