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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA); SCREW, FIXATION, INTRAOSSEOUS

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SYNTHES (USA); SCREW, FIXATION, INTRAOSSEOUS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Type  Injury  
Event Description
It was reported that patient with prior lefort i bilateral sagittal split osteotomy procedure was returned to the operating room on (b)(6) 2014 for revision.Patient presented to surgeon on an unknown date for post-op follow-up.Surgeon noticed patient's occlusion was not correct.The patient was returned to or where surgeon removed 3 matrixorthognathic screws on the patient's left side, and performed a bilateral sagittal split osteotomy to correct the patient's occlusion.A non-synthes dental splint was placed and the surgery was completed with no reported delay.This report is for 3 matrixorthognathic screws unknown part and lot numbers this is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional device info: this report is for 3 matrixorthognathic screws unknown part and lot numbers.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.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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Type of Device
SCREW, FIXATION, INTRAOSSEOUS
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 Key3775168
MDR Text Key16683607
Report Number2520274-2014-11075
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight66
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