MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The 510k: this report is for two (2) unknown titanium miniplates.Part and lot numbers are unknown; udi number is unknown.Implant/explant date: unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subsequent review of the following literature article: bormann (2010) sandwich osteotomy for vertical and transversal augmentation of the posterior mandible.International journal of oral and maxillofacial surgery, volume 39, pages 554-560.Germany.The aim of this study is to describe the treatment outcome after alveolar ridge augmentation in the atrophic posterior mandible by segmental sandwich osteotomy combined with an interpositional autograft prior to placement of endosseous implants.A total of 13 consecutive patients (5 males, mean age 48 years and 8 females, mean age 61 years) were included in this study.The cranial bone fragment was fixed to the mandibular base bone with 2 titanium miniplates and miniscrews (synthes (b)(4)) at 15 surgical sites; only 2 miniscrews were used at one surgical site; and no fixation except for a stable interposition was used at 6 surgical sites.The miniplates and miniscrews were removed 12 weeks after the reconstructive procedure.A total of 41 endosseous implants were placed using surgical templates.The minimum and the maximum follow-ups were 5 and 18 months (mean 12.07 months).The following complications were noted: patient 6 ¿ (b)(6) year old male underwent fixation with 2 screws only.Follow up period was 15 months.Patient experienced uneventful postoperative course.Patient had sensory disturbances in the mental nerve, with hypoaesthesia.The maximum duration of these sensory disturbances was 6 weeks.Patients did not complain of permanent sensory disturbances.Patient 7 ¿ (b)(6) year old female underwent fixation with 2 titanium miniplates and miniscrews.Follow up period was 10 months.Patient experienced uneventful postoperative course.Patient had sensory disturbances in the mental nerve, with hypoaesthesia.The maximum duration of these sensory disturbances was 6 weeks.Patients did not complain of permanent sensory disturbances.Patient 8 ¿ (b)(6) year old male underwent fixation with 2 titanium miniplates and miniscrews.Follow up period was 11 months.Patient experienced uneventful postoperative course.Patient had sensory disturbances in the mental nerve, with hypoaesthesia.The maximum duration of these sensory disturbances was 6 weeks.Patients did not complain of permanent sensory disturbances.Patient also had intraoral vestibular abscess was treated with drainage without any sequelae at follow-up.No dehiscence was observed during follow-up.Patient 10 ¿ (b)(6) year old male underwent fixation with 2 titanium miniplates and miniscrews.Follow up period was 16 months.Patient experienced uneventful postoperative course.Patient had sensory disturbances in the mental nerve, with hypoaesthesia.The maximum duration of these sensory disturbances was 6 weeks.Patients did not complain of permanent sensory disturbances.Patient 12 ¿ (b)(6) year old female underwent fixation with 2 titanium miniplates and miniscrews.Follow up period was 5 months.Patient experienced uneventful postoperative course.Patient had sensory disturbances in the mental nerve, with hypoaesthesia.The maximum duration of these sensory disturbances was 6 weeks.Patients did not complain of permanent sensory disturbances.Patient 13 ¿ (b)(6) year old female underwent fixation with 2 titanium miniplates and miniscrews.Follow up period was 8 months.Patient experienced uneventful postoperative course.Wound healing was affected by mucositis; this was resolved without sequelae.This report is for two (2) unknown titanium miniplates.This report is for patient 8 who had intraoral vestibular abscess postoperatively.This is report 1 of 2 for complaint (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7341553
• MDR Text Key: 102499885
• Report Number: 8030965-2018-52094
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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: 02/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR