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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 Pain (1994)
Event Date 06/22/2021
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: zhao b. , xioa q. , liu b. , (2021) effects of high tibial osteotomy combined with arthroscopy on pain and inflammation markers in patients with medial knee osteoarthritis, journal of investigative surgery volume xxxx, pages 1-8 (china). This study aims to explore the effects of hto combined with arthroscopy in patients with medial knee osteoarthritis, which may provide a basis for improving the prognosis of patients with medial knee osteoarthritis. From august 2019 to june 2020, a total of 82 patients with medial knee osteoarthritis were admitted. After randomization, 41 cases (19 males and 22 females) aged 49¿69 years old (58. 83 ± 8. 21 years) were enrolled in hto-a group and 41 cases (20 males and 21 females ) aged 48¿70 years old (58. 37 ± 8. 45 years) in hto group. Hto-a group was treated with hto combined with arthroscopy using tomofix titanium plate (depuy synthes, johnson & johnson medical devices companies). The following complications were reported as follows: shows that the pain degree of hto-a group is significantly lower than those of hto group on 1, 3 and 6 months after operation. Shows that the levels of interleukin-1, interleukin-6 and interleukin-17 are similar between the two groups before surgery, while the levels are significantly lower in hto-a group than those in hto group on 1, 3 and 6 months after surgery. This report is for an unknown synthes tomofix titanium plate. This report is for one (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 Key12547705
MDR Text Key273984605
Report Number8030965-2021-08120
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,literature
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was 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

Patient Treatment Data
Date Received: 09/29/2021 Patient Sequence Number: 1
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