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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI CORTEX SCREW SELF-TAPPING 20MM PLATE,FIXATION,BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI CORTEX SCREW SELF-TAPPING 20MM PLATE,FIXATION,BONE Back to Search Results
Catalog Number 404.82
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 08/10/2020
Event Type  Injury  
Manufacturer Narrative
Additional procode: hwc. 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. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during plate fixation, the first screw that the surgeon placed was the one in the oval hole. The surgeon was seeking to make an axial compression through the plate hole so he decided to place the immediate proximal screw to the oval one but was unsuccessful. Then, he decided to perform the same compression but in the immediate distal hole to the oval hole. When the surgeon decided to release the screws from the hole, the first screw broke. They didn't have an extraction set for broken screws so they decided to leave the screw. The outcome of the procedure was not reported. There was patient consequence. Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity unknown). This report is for one (1) 3. 5mm ti cortex screw self-tapping 20mm. This is report 1 of 1 for (b)(4).
 
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Brand Name3.5MM TI CORTEX SCREW SELF-TAPPING 20MM
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10488608
MDR Text Key208210728
Report Number8030965-2020-06584
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K131186
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number404.82
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 Received09/28/2020
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

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