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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/29/2014

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: seol g.J., et al (2014) reconstruction plates used in the surgery for mandibular discontinuity defect, korean assoc oral maxillofac surg volume 40, pages 266-271 (korea, south).This study aims to evaluate the factors associated with postoperative complications and analyze the survival rate of the mandibular reconstruction plate.Between 2004 and 2013, 36 patients (20 male and 16 female) with mean age of 45.7±17.0 years, who had discontinuity defects were included among a total of 77 patients who underwent reconstruction plate procedures.Patients underwent a surgical operation and reconstruction plates, synthes reconstruction plates (synthes, westchester, pa, usa) or jeil medical maxi plates 2.4 (jeil medical, seoul, korea) were used to correct the mandibular discontinuity defect and to reconstruct the defect.Twenty-seven synthes reconstruction plates and nine jeil medical maxi plates were used for the mandibular reconstruction.The mean follow-up period was 23.9±20.0 months (median 19 months) and ranged from 1 week to 7 years and 6 months.Reported complications: patient 1, 42-years-old male, implanted with synthes reconstruction plate , had screw loosening (the reason for plate removal).Patient 2, 70-year-old male , implanted with synthes reconstruction plate ,had plate fracture and underwent plate removal.Patient 3, 57-year-old male, implanted with synthes reconstruction plate , had screw loosening.Refused the removal surgery.Patient 7, 48-year-old female, implanted with synthes reconstruction plate ,had plate fracture and underwent plate removal.Patient 8, 48-year-old male, implanted with synthes reconstruction plate, had plate fracture and underwent plate removal.This report is for an unk - plate: reconstruction this is report 5 of 5 for (b)(4).

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.This report is for an unknown plate: reconstruction/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.

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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: UNK - PLATES: RECONSTRUCTION
• 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: 15793940
• MDR Text Key: 303639925
• Report Number: 8030965-2022-09785
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/22/2022
• 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): Other