MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BONE PLATE

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This information is unknown.Date of event is unknown.This report is for an unknown maxillary distractor system.Part and lot numbers are unknown; udi number is unknown.Date of implantation / explantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made, the investigation will be updated as applicable.(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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: takahashi, k.Et al (2017), patient with cleft maxillary hypoplasia who underwent distraction osteogenesis and conservative therapies to postoperative velopharyngeal insufficiency, journal of craniofacial surgery, vol.28 no.5, pages 1302-1304 (japan).This is a clinical report of a 19-year-old male who underwent le fort i osteotomy and was applied an unknown synthes maxillary distractor system for the treatment of maxillary retrusion, malalignment of teeth and malocclusion.Post-operatively, there was difficulty in controlling the direction by the distraction osteogenesis alone technically, and correction of the mandibular asymmetry of this case in addition to severe maxillary hypoplasia was needed.The osteogenesis distraction apparatus was removed and then plate fixation for the maxilla and bilateral sagittal split ramus osteotomy (ssro) was performed using an unknown device.This report is for an unknown synthes maxillary distractor system.This is report 1 of 1 for (b)(4).

• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7723625
• MDR Text Key: 115139328
• Report Number: 8030965-2018-55294
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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
• Date Manufacturer Received: 07/10/2018
• 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
• Patient Age: 19 YR