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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES USA ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Packaging Problem (3007)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Upon receipt of the additional information this complaint was reviewed and it was detected that this reported device (locking cap) requires its own complaint. Therefore a new complaint (b)(4) has been opened and this report for locking cap is retracted and will be reported under the new complaint (b)(4). 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
Date of event is approximately one year ago additional device product codes: mni, mnh, kwp, kwq this report is for one (1) unknown end cap. Part and lot numbers are unknown. Without a specific part and lot numbers, the udi is not available. Device is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(6). (510k): unknown, as specific part and lot numbers for end cap is not provided. Patient code (b)(4) is used as the package was missing an end cap which led to the surgeon putting in the screw without an end cap. The patient eventually needed a revision surgery prompted by a loosening screw. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Event Description
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon performed a surgery approximately one year ago. The surgeon used a click'x pedicle screw but the implant box missed a blocker (end cap). As the patient was already anesthetized the surgeon decided to keep the procedure and left the screw without blocking. During the surgery on (b)(6) 2017 it was noted that the screw was loose. No information available about patient condition and outcome. This report is for one (1) unknown end cap. This is report 2 of 2 for complaint (b)(4).
 
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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 Key6595495
MDR Text Key114563061
Report Number2520274-2017-11734
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received07/19/2017
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: 05/26/2017 Patient Sequence Number: 1
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