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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA SCREW, FIXATION, BONE Back to Search Results
Device Problem Appropriate Term/Code Not Available
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative

Date of event is an unknown date in 2019. This report is for an unknown screw/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. 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)(6) reports an event as follows: it was reported that patient was scheduled for a multiloc implantation on an unknown date. Instead of receiving two modules of multiloc implants and instruments, the client received the instrument module multiloc and the pin han screws. The surgery had originally been planned as a minimally evasive clamping surgery and with the patient anesthetized, the surgeon had to change the procedure to a large extension approach with osteosynthesis with philos plate. The surgery was more time consuming and more traumatic by the extension of the incision. Procedure was completed successfully with a two (2) hour delay. Patient is recovering without problem. This report is for an unknown screw. This is report 3 of 3 for (b)(4).

 
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Brand NameUNK - SCREWS: TRAUMA
Type of DeviceSCREW, 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 Key8874680
Report Number8030965-2019-67018
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2019
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 Received07/10/2019
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: 08/08/2019 Patient Sequence Number: 1
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