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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES (USA) ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient information is not available for reporting. Date of event: date unknown. Additional device product code are: mni, mnh, kwp, kwq. This report is for 1 unknown rod. Part and lot numbers were not provided by reporter. Udi: unknown part number, udi is unavailable. Implant date unknown. The subject device is not expected to be returned to the synthes manufacturer for evaluation. (b)(4). This report is for 1 unknown rod. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that patient had a revision surgery on (b)(6) 2016 for removal of pangea implants. The reason for the revision surgery is unknown. Patient was originally implanted on an unknown date and unknown reason in the left pedicle at l4-s1 disc space with posterior pedicle screws and rod fixation. The surgeon removed one rod, three screw and three locking caps. It was observed that the removed implants had no issues. It is unknown what the patient was revised to. Patient status/outcome is unknown. Procedure was successfully completed with no surgical delay. This report is for 1 unknown rod. This report is 3 of 3 for (b)(4).
 
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Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5942885
MDR Text Key54434574
Report Number2520274-2016-14490
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/12/2016 Patient Sequence Number: 1
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