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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH; SCREW,FIXATION,BONE Back to Search Results
Device Problems Failure to Cut (2587); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 an unknown date, during an unknown procedure, the 2.4 mm headless compression screw and unknown 3.0 mm headless compression screw cannot be inserted.When the surgeon tried to insert the screws into the bone, it was hard to advance them.The surgeon felt that self-drilling function of the screws was worse than that of another company¿s headless compression screws.Hence, the surgeon requested to improve the design of the hcs so that self-drilling function will be improved.The surgery was completed successfully though it is unknown how was the surgery completed.Patient and procedure outcome were unknown.This report is for one (1) screws: 2.4 mm and 3.0 mm headless compression.This is report 2 of 2 for (b)(4).
 
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Type of Device
SCREW,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 Key8577732
MDR Text Key143977596
Report Number8030965-2019-63438
Device Sequence Number1
Product Code HWC
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 Physician
Type of Report Initial
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2019
Initial Date FDA Received05/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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