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

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

Patient Problems Fistula (1862); Unspecified Infection (1930)

Event Date 12/30/2017

Event Type  Injury  

Manufacturer Narrative

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/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: offodile ii, ac et al (2018).Anterolateral thigh flap combined with reconstruction plate versus double free flaps for composite mandibular reconstruction: a propensity score-matched study.Annals of surgical oncology.Volume 25.Pages 829-836.(taiwan) this retrospective study aims to examine the comparative effectiveness of oromandibular defect reconstruction via anterolateral thigh flap and bridging plate (alt only) versus simultaneous soft tissue and vascularized bone flap (dff), with regards to long-term plate exposure and complications.Between january 2008 and june 2013, 160 patients underwent microvascular reconstruction of a composite oromandibular defect following oncologic extirpation.62 patients were 1:1 propensity-matched and were included in the study.2 surgical groups were created, the alt only group (31 patients with 29 males, an average age of 54.3+/-10.3 years) and the dff group (31 patients with 30 males, an average age of 52.0+/-12.4 years).The unknown synthes locking mandibular reconstruction plate fixation system was used to span the mandibular defect or secure the free flap (ff) in all cases.Post-operative assessment included pain, appearance, employment, speech, and swallowing.Scoring is based on a scale of 0 (worst) to 100 (best), and all patients received the questionnaire at least 12 months after surgery.Complications were reported as follows: (alt only group)- 1 patient had a medical complication.12 patients had wound infection or fistula.5 patients underwent debridement.12 patients had plate exposure.3 patients were treated conservatively.8 patients had only the plates removed.1 patient had the plate and 2nd flap (vascularized fibula flap) removed.21 patients had a soft or liquid diet.6 patients had a partial tube feeding.4 patients had a total tube feeding.Pain mean score of 75.2 ± 10.1 per qol evaluation.Swallowing mean score of 75.3 ± 22.1 per qol evaluation.Speech mean score of 72.1 ± 23.5 per qol evaluation.Appearance mean score of 55.3 ± 19.9 per qol evaluation.Employment mean score of 42.3 ± 27.1 per qol evaluation.1 patient had plate fracture.(dff group)- 5 patients had a medical complication.4 patients had wound infection or fistula.7 patients underwent debridement.11 patients had plate exposure.10 patients had only the plates removed.1 patient had the plate and 2nd flap (alt flap)removed.22 patients had a soft or liquid diet.6 patients had a partial tube feeding.3 patients had a total tube feeding.Pain mean score of 88.5 ± 10.3per qol evaluation.Swallowing mean score of 81.2 ± 28.9 per qol evaluation.Speech mean score of 80.3 ± 35.2 per qol evaluation.Appearance mean score of 62.1 ± 23.2 per qol evaluation.Employment mean score of 43.2 ± 28.5 per qol evaluation.This report is for one (1) unknown synthes locking mandibular reconstruction plate fixation system.This is report 1 of 3 for (b)(4).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8148093
• MDR Text Key: 129878810
• Report Number: 8030965-2018-58884
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• 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: 11/19/2018
• 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