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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PLATES: TIBIA PLATE,FIXATION,BONE Back to Search Results
Device Problem Break (1069)
Patient Problem Swelling/ Edema (4577)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown plates: tibia/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.

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the right tibial fracture was treated with open reduction and plate internal fixation under spinal epidural anesthesia. The patient was implanted with an unknown tibial plate. On (b)(6) 2021, the patient experienced local deformation and swelling at the surgical fixation site. The breakage of the plate was diagnosed by x-ray. After communication, the patient was re-operated on june 4 under spinal epidural anesthesia and the broken plate was replaced. The operation went well. No additional information could be provided. This complaint was reported by the health authority. This report is for one (1) unk - plates: tibia. This is report 1 of 1 for (b)(4).

 
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Brand NameUNK - PLATES: TIBIA
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12289653
MDR Text Key265468163
Report Number8030965-2021-06494
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/23/2021
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: 08/06/2021 Patient Sequence Number: 1
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