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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: DHS/DCS PLATE,FIXATION,BONE

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SYNTHES GMBH UNK - PLATES: DHS/DCS PLATE,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown dhs plate/unknown lot. Part and lot numbers are unknown; udi number is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
It was reported that on an unknown date, during a procedure the device did not adapt with the plate. Another device was used to complete the procedure. This report is for one (1) unk - plates: dhs/dcs this is report 2 of 2 for complaint (b)(4).
 
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Brand NameUNK - PLATES: DHS/DCS
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13368331
MDR Text Key290282586
Report Number8030965-2022-00577
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/27/2022 Patient Sequence Number: 1
Treatment
DHS/DCS-SCR Ø12.5 L105 SST; UNK - SCREWDRIVERS
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