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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 Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
This report is for unknown plate. Part#, lot# and udi # is not available. Device is not expected to be returned for manufacturer review/investigation. This report is for unknown plate. Pma/510(k) number is not available. Product was not returned. Device history records review could not be completed without lot number. Based on the information available, it has been determined that no corrective and 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: r. Nadarajah, j. Mahaluxmivala, a. Amin, d. W. Goodier (2005). Clavicular hook-plate: complications of retaining the implant. International journal of the care of the injured. Page 681-683. ((b)(6)). The present article reports a case of a clavicular fracture at the medial end of a retained implant following a low energy fall. A (b)(6) right-handed manual laborer was involved in a medium velocity road traffic accident where he was thrown off his motorbike and landed heavily on his right arm and shoulder. The patient presented with a closed grade v (rock-wood and green) acromioclavicular joint dislocation with no associated neurovascular deficit. The patient opted for surgical stabilization with a hook-plate device. No attempt was made to repair the coracoclavicular or acromioclavicular ligaments. There were no peri-operative complications and the patient was discharged home 2 days later. A year after the patient's initial injury, the patient represented with a closed fracture of the clavicle at the medial end of the plate as seen in figure 1 after a low-velocity fall from his bicycle landing directly on to his right shoulder. The patient then underwent removal of the hook plate. A contoured, narrow 9-hole dcp plate was used to stabilize the fracture and this was supplemented with ipsilateral iliac crest bone graft at the fracture site to promote bony healing (figure 2). Post-operative radiographs (figure 2) show considerable osteolysis around the joint. This report is for unknown clavicle hook plate. This is report 2 of 3 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8230838
MDR Text Key132494223
Report Number8030965-2019-59640
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 12/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/30/2018
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: 01/09/2019 Patient Sequence Number: 1
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