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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ORTHOSIS, SPINAL PEDICLE

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SYNTHES USA ORTHOSIS, SPINAL PEDICLE Back to Search Results
Device Problem Bent (1059)
Patient Problem Impaired Healing (2378)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Literature article received: this report is being filed after the subsequent review of the following literature article: kokabu, t. , et al. (2016) effects of multilevel facetectomy and screw density on postoperative changes in spinal rod contour in thoracic adolescent idiopathic scoliosis surgery. Plos one 11(8): e0161906. Doi:10. 1371/journal. Pone. 0161906. The study was an investigator-initiated observational cohort study conducted at a single medical center and approved by institutional review board. Data from 49 patients (1 male, 48 female) with lenke type 1 or type 2 ais curves who underwent posterior thoracic curve correction between june 2009 and april 2016 were evaluated. Six-millimeter diameter titanium-alloy implant rods and polyaxial pss (uss ii polyaxial, depuy synthes, (b)(4)) were used to correct the scoliosis deformity. All rods were prebent only at a single plane. There was a significant relationship between postoperative thoracic kyphosis (tk) and the postoperative implant rod angle of curvature. The rod at the concave side was significantly deformed after the surgical treatment. This is report 1 of 1 for (b)(4). This report is for unknown rods.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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 DeviceORTHOSIS, SPINAL PEDICLE
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 Key6030733
MDR Text Key57484072
Report Number2520274-2016-14910
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUNKNOWN
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 Received10/26/2016
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: 10/14/2016 Patient Sequence Number: 1
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