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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: RECONSTRUCTION PLATE, FIXATION, BONE Back to Search Results
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.
 
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Brand NameUNK - PLATES: RECONSTRUCTION
Type of DevicePLATE, 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 Key8772746
MDR Text Key150532897
Report Number8030965-2019-66099
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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 Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/09/2019 Patient Sequence Number: 1
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