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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TRAUMA PLATE,FIXATION,BONE

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SYNTHES GMBH UNK - PLATES: TRAUMA PLATE,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent an unknown surgery. During the surgery, when the guiding block in question was attached to a plate, the guiding block was unstable. The surgeon reattached the guiding block to the plate, but the guiding block did not stabilize and remained unstable. The guiding block in question was compared to other sizes of guiding blocks, but it seemed nothing abnormal. In the surgery, the plate was inserted without using any guiding blocks. The surgery was completed successfully without surgical delay. The patient outcome was reported as stable. No further information is available. This report is for one (1) unk - plates: trauma. This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
This report is for an unknown plates: trauma/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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.
 
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Brand NameUNK - PLATES: TRAUMA
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13114339
MDR Text Key286515074
Report Number8030965-2021-10545
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
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 Received12/01/2021
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: 12/29/2021 Patient Sequence Number: 1
Treatment
GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 N
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