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U.S. Department of Health and Human Services

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

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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); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(6). Additional product codes: mni, mnh, kwp, kwq. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Subject device has not been received. Without a lot number, the device history record review and 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 is reported patient was implanted with synthes uss (universal spine system) at l5-s1 approximately 1 year prior. Patient did not heal and a non-union exists at that level. Patient was returned to o. R. On (b)(6) 2016 where surgeon first removed a mtf t-plif spacer from the l5-s1 disc space and performed an alif with a mtf fra allograft. Patient was then repositioned to prone for the posterior revision. Surgeon removed all of the uss hardware at l5-s1 and placed new uss screws and upsized the screw diameters by one mm for each screw. New rods were then placed and the procedure was completed successfully with no delay or harm to patient. There is no allegation against the explanted hardware. This report is 12 of 13 for (b)(4).
 
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Brand Name6.0MM TI COLLAR
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
MDR Report Key5411704
MDR Text Key37517984
Report Number2520274-2016-10824
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 01/20/2016
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? 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 Received01/20/2016
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: 02/04/2016 Patient Sequence Number: 1
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