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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH SCREW, FIXATION, BONE Back to Search Results
Device Problems Unintended Movement; Migration
Event Type  Injury  
Manufacturer Narrative

Patient information is not available for reporting. Date of event: unknown. This report is for an unknown synthes 1. 5mm diameter orthodontic bone anchor screw/unknown lot. Part and lot number are unknown; udi number is unknown. Implanted, explanted dates: unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (510k): unknown, as specific part and lot numbers for 1. 5mm diameter orthodontic bone anchor screw is not provided. 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. (b)(4).

 
Event Description

This report is being filed after the review of the following journal article: andrei florescu v, kofod t, pinholt em, et al (2016). Intermaxillary fixation screw morbidity in treatment of mandibular fractures¿a retrospective study. Journal of oral and maxillofacial surgery. Volume 74. Issue 9. Pages 1800-1806. (denmark). The aim of the present retrospective study was to investigate the morbidity of screws used for intermaxillary fixation (imf) in the treatment of mandibular fractures and to compare the results with those from published reports. From 2007 to august 2013, a total of 156 patient with mandibular fractures who underwent intermaxillary fixation (imf) with screws were included in the study. 78 patients were implanted with an unknown synthes orthodontic bone anchor screws, 1. 5 mm in diameter while the rest of the patients were implanted with a competitor¿s device. The average number of screws per patient was 5. The article did not specify if the complications experienced were involving patients implanted with the synthes screws. Therefore, all complications will be reported as follows: two patients had central iatrogenic damage to dental roots. Seven patients had peripheral iatrogenic damage to dental roots. One patient had screw loss. Two patients experienced no healing or secondary healing. Three patients had a lack of habitual occlusion. Fifteen patients had screw loosening. This report is for a patient who experienced screw loss (migration) and 15 patients who experienced screw loosening. This report is for an unknown synthes 1. 5mm diameter orthodontic bone anchor screw. This is report 2 of 2 for (b)(4).

 
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Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
michael cote
1302 wright lane east
west chester , PA 19380
6107195000
MDR Report Key7712742
Report Number8030965-2018-55224
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
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: 07/23/2018 Patient Sequence Number: 1
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