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

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

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Injury (2348); No Code Available (3191)

Event Date 09/23/2003

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown reconstruction plates/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: shaw, r.J.Et al (2004), comparison of miniplates and reconstruction plates in mandibular reconstruction, head and neck, vol.26 (5), pages 456-463 (united kingdom).The aim of this retrospective study is to compare complication rates of miniplates versus reconstruction plates in the fixation of vascularized grafts into segmental mandibular defects.Between 1993 to 2001, a total of 143 patients (87 males and 56 females) were included in the study.Reconstruction plates were used as fixation in 73 patients (unknown number of patients were implanted with stratec/synthes ao 2.4-mm titanium reconstruction).The amount of follow-up was median 2.3 years.The following complications were reported as follows (the article did not specify how many patients were implanted with synthes device): 3 patients had plate complications (bone removal) that required for readmission or reoperation.16 patients had plate complications (infection) are required for readmission or reoperation.15 patients had plate complications (plate removal) that required for readmission or reoperation.6 patients had plate complications (plate exposure) are required for readmission or reoperation.22 patients had plate complication are required for readmission or reoperation due to any plate complications.Survival rates from operation using reconstruction plates was 85% at 1 year and 55% after 3 years.This is report 3 of 3 for (b)(4).This report is for an unknown synthes reconstruction plates.

• Brand Name: UNK - PLATES: RECONSTRUCTION
• 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: 8772746
• MDR Text Key: 150532897
• Report Number: 8030965-2019-66099
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• 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