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U.S. Department of Health and Human Services

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

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SYNTHES (USA) OSTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Break (1069)
Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
Patient initials: (b)(6). Patient weight is unknown. This report is for an unknown rod/unknown lot. Part and lot numbers are unknown; udi number is unknown. Additional product codes: mni, mnh, kwp, kwq. Implant date: (b)(6) 2014. Device has not been explanted. 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. Device was used for treatment, not diagnosis. 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 a patient underwent a l1 - ilium posterior fusion with a synthes universal spine system (uss) system on an unknown date in (b)(6) 2014. At an unknown time, the patient developed a non-union at the l5-s1 level. It was also reported the patient had pain, irritation or discomfort. On (b)(6) 2015 an anterior lumbar inter-body fusion (alif) revision surgery was performed on the patient to address the l5-s1 non-union. The surgery was successfully completed. Prior to the revision surgery, no hardware issues were observed with the l1-ilium uss hardware, and there were no plans to revise the posterior hardware in the patient's treatment plan. During the alif procedure, the surgeon observed that the left rod had a hairline fracture between the s1 and the iliac screw. This was discovered when looking at imaging. The surgeon does not anticipate any further treatment intervention on the posterior hardware. There was no reported patient harm, no reported delay to the surgical procedure. All devices remain implanted and will not be returned. This report is for an unknown rod. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Partial part number of 498. 10x was provided. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Type of DeviceOSTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5410008
MDR Text Key137670545
Report Number2520274-2015-18070
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,Followup
Report Date 12/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received02/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/04/2016 Patient Sequence Number: 1
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