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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 8.0MM TI SIDE-OPENING SCREW 45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES USA 8.0MM TI SIDE-OPENING SCREW 45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 498.863
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). Unknown when non-union, pain, discomfort or irritation occurred. (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 or 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 hardward 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 5 of 13 for (b)(4).
 
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Brand Name8.0MM TI SIDE-OPENING SCREW 45MM
Type of DeviceORTHOSIS, 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 Key5411691
MDR Text Key37517873
Report Number2520274-2016-10804
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
0 Patients were Involved in the Event:
Date FDA Received02/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number498.863
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

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