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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 6.0MM TI COLLAR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES USA 6.0MM TI COLLAR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 498.010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Patient weight is unknown. Additional product codes for this report include mni, mnh, kwp, and kwq. (b)(4). Date of original implant procedure is unknown. Per facility, the complainant parts were returned to the patient and are not available for manufacturer evaluation. (b)(4). Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. Device 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 posterior spinal fusion procedure from t10-l3 with synthes universal spine system (uss) instrumentation on an unknown date. Thereafter, the patient achieved a solid fusion at the t10-l3 level with no hardware related issues. At an unknown time, however, the patient developed junctional kyphosis above the level of fusion (t10 level) and stenosis below the level of fusion at the l5 level. Pain, irritation, and discomfort were also noted. As a result, the patient was returned to the operating room for revision on (b)(6) 2015. During the revision, the rods were removed and the purchase of all screws was checked. Eight (8) of the twelve (12) screws between t10 and l3 were removed and replaced with larger diameter uss screws. Also, new bilateral screws were placed at t7, t8, t9, l4, s1, and ilium. A decompression was performed at l4-l5 and new rods were contoured then connected from t7-ilium. The procedure was successfully completed. This report is 6 of 10 for (b)(4).
 
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Brand Name6.0MM TI COLLAR
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5363931
MDR Text Key35801404
Report Number2520274-2016-10191
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK082572
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 12/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number498.010
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 Received12/28/2015
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: 01/13/2016 Patient Sequence Number: 1
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