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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PLATES: RECONSTRUCTION; PLATE, FIXATION, BONE Back to Search Results
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.
 
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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 Key15793940
MDR Text Key303639925
Report Number8030965-2022-09785
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
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 Received11/14/2022
Supplement Dates Manufacturer Received12/01/2022
Supplement Dates FDA Received12/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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