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

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problem Failure of Implant (1924)

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).

• Type of Device: SCREW, 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 Key: 7712742
• MDR Text Key: 114800214
• Report Number: 8030965-2018-55224
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention