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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Inflammation/ Irritation (4545); Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). This report is for an unk - plates: tomofix osteotomy /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 as no product was received. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of the following journal article: wang x. , et al (2021) salvage of severe knee osteoarthritis: efficacy of tibial condylar valgus osteotomy versus open wedge high tibial osteotomy, journal of orthopedic surgery and research volume 16: pages 1-11 (china) this retrospective study aims to present a comprehensive comparison between two types of osteotomy in terms of radiological assessment and clinical evaluations, and it also shed new insight on the indication criteria for tcvo. September 2015 to october 2018, patients who received osteotomy were evaluated. A total of 63 oa knees from 46 cases, with complete medical records and a minimum follow-up of 26 months, were included in the study. Thirty-four oa knees from 22 cases (10 males,12 females) age 56 (40¿74 years) with lateral joint dilation (jlca over 4°) and depression of the medial tibial plateau (mtpd less than - 4°) underwent tibial condylar valgus osteotomy (tcvo) surgery. Open-wedge high tibial osteotomy (owhto) was performed on the rest 24 cases (12 males, 12 females) 29 oa knees with age 59 (43¿75 years). In owhto procedure a tomofix¿ plate with interlocking screws was used for internal fixation of the osteotomy site while in the tcvo procedure the anteromedial aspect of the tibia was fixed by a t-shaped locking plate or a tomofixtm locking plate and stabilized with locking screws. For comparing the outcomes of these surgical procedures during severe varus deformity, 27 knees with a pre-operative fta
185° were defined as those with severe varus (subgroup s, 15 knees in 9 cases (3 males and 6 females ) age 57 (45¿68 years ) in stcvo group and 12knees in 10 cases (4 males, 6 females) age 61 (51¿71 years) in shto group). Tcvo was followed up at 35 (27¿42) months and hto group at 33 (27-65) months. The following complications were reported: - mtpd increased to 5. 9 ± 2. 5° (p < 0. 05) in tcvo group. -increased in terms of limb alignment, %ma in tcvo group. -under corrected knees 13. 3% in tcvo group. -opening angle and distance of the opening gap were larger in tcvo group (19. 1° and 14. 0 mm) -one skin irritation in owhto group. - mtpd was relatively the same before and after owhto. -increased in terms of limb alignment, %ma in owhto group. -higher rate of under corrected knees (post-operative fta over 175°) was observed in the shto. This report is for an unknown synthes tomofix¿ plate with interlocking screws and tomofix locking plate and stabilized with locking screws. A copy of the literature article is being submitted with this medwatch. This report is for (1) unk - plates: tomofix osteotomy. This report is 3 of 4 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
MDR Report Key12543547
MDR Text Key273758946
Report Number8030965-2021-08099
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 Received09/28/2021
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? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1