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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - RODS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Spinal Column Injury (2081); No Code Available (3191)
Event Date 09/27/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown - rods: spine/ unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventive 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 on (b)(6) 2019, the patient underwent revision surgery to remove some matrix pedicle screws and the revision was apparently for further decompression and re-fixation. After two screws were successfully removed the other screws would not get any purchase from the screwdriver. It was advised that the screws which couldn't be removed remained in the patient and were re-locked with the rods and set screws. It unknown if there were fragments generated. Unknown patient outcome. Procedure successfully completed. This complaint involves ten (10) devices. This report is for one (1) unk - rods. This report is 5 of 10 for (b)(4).
 
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Brand NameUNK - RODS
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key9231160
MDR Text Key176278916
Report Number8030965-2019-69607
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
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 Received10/28/2019
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: 10/23/2019 Patient Sequence Number: 1
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