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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - constructs: tomofix plate/screws/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
This report is being filed after the review of the following journal article: chen d. C. , et al (202) tranexamic acid is beneficial to patients undergoing open-wedge high tibial osteotomy, hindawi biomed research international volume xxxx, article id 2514207, pages 1-5 (china). This study aims to investigate the efficacy of txa in patients undergoing owhto. From august 2018 to may 2020, a total of 52 patient (20 males and 32 females) with mean age of 58:3 ± 10:4 years were enrolled in the ta group, and 48 patients (22 males and 32 females) with mean age of 56:6 ± 10:2 years were enrolled in the nta group. (ta group) were administered intravenous tranexamic acid 1 g before tourniquet inflation and topical tranexamic acid 1 g at osteotomy site; patients in the nontranexamic acid group (nta group) did not receive any additional treatment. The osteotomy site was fixed with tomofix plate system. The following complications were reported as follows: thrombotic events 2 in ta group and 4 in nta group. Hematoma 2 in ta group and 5 in nta group. Infection 1 in ta group and 2 in nta group. This report is for an unknown synthes tomofix plate system. This report is for (1) unk - constructs: tomofix plate/screws. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS
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 Key12547055
MDR Text Key274007331
Report Number8030965-2021-08115
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,l
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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