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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown plate/unknown lot. Part and lot number 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. (b)(4). 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

Device report from (b)(4) reports an event as follows: it was reported that on (b)(6) 2018, the distributor placed an order for a surgery scheduled for the following day. The distributor requested variable angle-distal humerus plates (va-dhp) and an additional hook plate since there is a possibility that an osteotomy will be performed. On (b)(6) 2018, after a general anesthetic was applied to the patient, the devices were checked with the surgeon and it was made known that an extra-long plate which had not been ordered was necessary for the surgery. The surgeon judged that the affected site could not be properly fixed without the extra-long plate, thus, the operation was postponed to the following day, (b)(6) 2018. Currently, the patient is in the hospital. This report is for an unknown plate. This is report 1 of 1 for (b)(4).

 
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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 Key8204087
MDR Text Key131701685
Report Number8030965-2018-59308
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2018
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: 12/28/2018 Patient Sequence Number: 1
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