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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: fernandes tb, et al.(2022), efficiency of the 2-mm titanium lambda plate for open reduction and internal fixation of subcondylar fractures of the mandible: a prospective clinical study, j.Maxillofac.Oral surg., volume 21, number 2, pages 379¿385 (india) this study aims to carry out clinical in vivo evaluation of efficiency of the 2-mm lambda plate for open reduction and internal fixation of condylar fractures.From march 2017 to august 2018, 16 patients who underwent open reduction for subcondylar fractures of the mandible and fixation using a 2-mm 7-holed titanium lambda miniplate were included in the study.There were 15 males and 1 female with a mean age of 28.9 years (range 22 to 51 years).Fixation was carried out using the 2-mm 7-holed titanium unknown synthes matrixmandible lambda plate secured with at least (2) 6-mm monocortical screws on either side of the fracture line.Post-operatively patients were broadly advised a soft to normal diet for 4¿6 weeks, as per their pain and comfort levels, and were immediately encouraged to practice mouth opening.Complications were reported as follows: 1 patient had hardware failure.The patient presented with an extraoral draining sinus at 1 month follow-up visit.Ct demonstrated evidence of plate fracture.The plate was found to be fractured at the junctional connecting strut between the anterior arm and the posterior arm.The plate was then immediately retrieved under general anaesthesia, followed by intermaxillary guiding elastics for 2 weeks as pain and mandibular deviation on maximal opening was noted.On subsequent follow-up visits, the surgical site appeared healthy and the patient was asymptomatic with adequate mouth opening and satisfactory occlusion.This report is for the unknown synthes matrixmandible lambda plate.This is report 1 of 1 for complaint (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unknown plates: matrixmandible/unknown lot.Part and lot numbers are unknown; udi 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.

• Brand Name: UNK - PLATES: MATRIXMANDIBLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15536157
• MDR Text Key: 301110621
• Report Number: 8030965-2022-07775
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• 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: 09/15/2022
• 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