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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA USS-II-POLYAXIAL CANCELLOUSSCR Ø8 L80 TA ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES USA USS-II-POLYAXIAL CANCELLOUSSCR Ø8 L80 TA ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 04.607.281S
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Sedation (2368); No Code Available (3191)
Event Date 01/25/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Implanted/explanted on the same day. Device is not expected to be returned for manufacturer review/investigation. Patient code (b)(4) used for: a screw migrated post-operatively, which required revision surgery. 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
Device report from synthes on an event in (b)(6) as follows: the original surgery was performed for the sacral fracture, covering s1-iliac, on (b)(6) 2017. After the surgery, x-rays were taken and showed that the screw, fixed on the left ilium, had migrated inward. So the surgeon decided the subsequent screw replacement surgery ((b)(4)). There is no information available about patient and surgical outcome. This complaint involves 1 part. This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
On march 14, 2017 it was realized that the complained part associated with this report was returned under related complaint (b)(4) on february 08, 2017. A product investigation was completed: visual inspection has shown that the uss-ii polyaxial cancellous bone screw has slight marks of use. No other damage could be found. The complained issue could not be replicated and/or confirmed as no x-rays were returned which would confirm the migration. Complaint is unconfirmed. The root cause for this complaint could not be defined with the available information. No indication for product related issue was found. 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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Brand NameUSS-II-POLYAXIAL CANCELLOUSSCR Ø8 L80 TA
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 Key6347938
MDR Text Key67925125
Report Number2520274-2017-10558
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082572
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 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.607.281S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
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: 02/21/2017 Patient Sequence Number: 1
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