MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: MATRIXMANDIBLE; PLATE, FIXATION, BONE

Device Problem Device Slipped (1584)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrixmandible plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 available, the investigation will be updated as applicable.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: smolka, w., liokatis, p., and cornelius, c.P.(2020), evaluation of complications after open reduction and internal fixation of mandibular condylar base and neck fractures using trapezoidal plates, the journal of craniofacial surgery, vol.Xx (xx), pages 1-4 (germany).The aim of this is to evaluate the fracture pattern of patients that had been treated with trapezoidal-shaped plate fixation of condylar base and neck fractures using the aocmf classification system, to find out if a specific fracture pattern is associated with failure of trapezoidal-shaped plate fixation.Between 2011 to 2016, a total of 10 female patients (12 fractures) with a mean age of 56 years (range 36-72 years) underwent open reduction and internal fixation.Surgery was performed using a 3-dimensional matrixmandible trapezoidal plate (depuy synthes, paoli, pa).The mean follow-up was 5 months (range 3-15 months).The following complications were reported as follows: 1 patient, who had bilateral condylar neck fractures combined with a symphysal fracture (fig.1), had a screw and plate loosening appeared only on the right side within 1 week after surgery.This resulted into medial displacement of the proximal fracture fragment and shortening of the ramus height.1 patient, who had a unilateral condylar neck fracture without additional fractures (fig.2), had a screw and plate loosening noted 16 weeks postoperatively.This resulted into medial displacement of the proximal fracture fragment and shortening of the ramus height.This report is for an unknown synthes matrixmandible plate.It captures the reported 1 patient who had a screw and plate loosening noted 16 weeks postoperatively which resulted to medial displacement of the proximal fracture and shortening of the ramus height.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - PLATES: MATRIXMANDIBLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10350873
• MDR Text Key: 201245522
• Report Number: 8030965-2020-05534
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 07/10/2020
• 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