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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PLATES: CONDYLAR PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK - PLATES: CONDYLAR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Date 03/12/2022
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2011, the patient underwent the tka surgery at another hospital. After surgery, on unknown date, the supracondylar fracture occurred, and the revision surgery was performed with the plate in question. After revision surgery, non-union occurred. The second revision surgery will be performed on (b)(6) 2022, for treatment of non-union. In the second revision surgery, a retrograde nail will be inserted from intercondyle. No further information is available. Unk - nail (part# unknown; lot# unknown; quantity: unknown). This complaint involves one (1) device unk - plates: condylar. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). Additional narrative: 510k: this report is for an unknown distal condylar plate/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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: CONDYLAR
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14054110
MDR Text Key288885817
Report Number8030965-2022-02315
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 Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - PLATES: CONDYLAR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/08/2022 Patient Sequence Number: 1
Treatment
UNK - NAIL
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