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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2009

Event Type  Injury  

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.

Event Description

This report is being filed after the review of the following journal article: el-zohairy, m.Af.Et al.(2009), mandibular reconstruction using pectoralis major myocutaneous flap and titanium plates after ablative surgery for locally advanced tumors of the oral cavity.The journal of the egyptian national cancer institute, vol.21 (4), pages 299-307.(egypt).The aim of this study is to evaluate outcomes of mandibular reconstruction using titanium plates covered with a pedicled pectoralis major myocutaneous flap after ablative surgery for locally advanced tumors of the oral cavity.Between january 2003 and december 2008, 33 patients (25 males and 8 females with mean age of 52.3±5.9 years) underwent lateral segmental resection (posterior to mental foramen) as a part of a composite procedure for oral cavity cancer.All patients had immediate mandibular reconstruction using 2.7mm or 2.4mm ao titanium reconstruction plates.Median follow-up period was 22.5 months (range, 12-36 months).The following complications were reported as follows: one patient developed wound dehiscence, another had a cervical abscess which needed drainage and, finally, in five cases, an oro-cutaneous fistula occurred which was managed conservatively with spontaneous closure within 30 days.Partial skin flap necrosis was observed in 3 patients.Three patients who had wound dehiscence, cervical abscess and partial skin flap necrosis developed also oro-cutaneous fistula.Late complications occurred in 4 (12.1%) patients.There were 4 cases of plate failure, one patient experienced plate fracture at 13 months after reconstruction and three patients (9.1%) experienced delayed extra-oral plate exposure between 5 and 9 months after primary oromandibular reconstruction, all needed removal of the plate without reconstruction.The contour of the mandible in the remaining 29 (87,9%) patients was satisfactory in that no marked unilateral asymmetry was observed.Fourteen patients died from their disease at the end of 2 years follow-up due to systemic metastases or local recurrence.This report is for an unk - plate: reconstruction.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: RECONSTRUCTION
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15805296
• MDR Text Key: 303726397
• Report Number: 8030965-2022-09878
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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

• Date FDA Received: 11/16/2022
• 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
• Date Manufacturer Received: 11/30/2022
• 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