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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 Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(6). This report is for one (1) unknown rod. Part#, lot# and udi # is not available. Initial implant procedure was done in (b)(6) 2015. Exact date is unknown. Device is not expected to be returned for manufacturer review/investigation. (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. 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 an initial procedure was performed in (b)(6) 2015 to address a sacral fracture that occurred as a result of a motorcycle accident to the patient. Originally implanted hardware was on the right side of the spine from l5-ilium, using two (2) screws, two (2) collars, two (2) nuts, and one (1) rod from the universal spine system (uss) set. No screw was implanted at s1 disc level. At an unknown point in time, the patient did not heal and develop a non-fusion. Also, the rod broke at the l5 disc level. A revision surgery was performed on (b)(6) 2017. Surgeon removed the rod, and then removed the l5 disc screw due to that fact that he thought it was a little loose and replaced it with one inch diameter size bigger screw. Surgeon left the iliac screw intact. Surgeon then contoured a new rod and connected it to the right l5 and right iliac screw position. Surgery was completed successfully and patient was reported in stable condition. Concomitant medical products: 6. 0mm titanium collar (part# 498. 010, lot# unknown, quantity 2); titanium nut 11mm width across flats (part# 498. 003, lot# unknown, quantity 2); 8. 0mm titanium side opening screw (part# 498. 87x (length of screw is unknown), lot # unknown, quantity 1). This report is for one (1) unknown rod. This is report 2 of 2 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6283876
MDR Text Key65999621
Report Number2520274-2017-10310
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 01/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
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: 01/27/2017 Patient Sequence Number: 1
Treatment
PART# 498.003, LOT# UNKNOWN, QUANTITY 2; PART# 498.010, LOT# UNKNOWN, QUANTITY 2; PART# 498.87X, LOT # UNKNOWN, QUANTITY 1
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