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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; FILLER, BONE VOID, CALCIUM COMPOUND

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SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; FILLER, BONE VOID, CALCIUM COMPOUND Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - biomaterial - preformed: chronos: trauma/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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: jung w., takeuchi r., kim d., nag r.,(2020) faster union rate and better clinical outcomes using autologous bone graft after medial opening wedge high tibial osteotomy, knee surgery, sports traumatology, arthroscopy volume 28, pages 1380¿1387 (korea, south).This study aims to assess radiological bone union rates and clinical outcomes between three different gap filling options in mow-hto using the tomofix¿ plate.From january 2014 to february 2017, surgery was performed on 280 knees that underwent mow-hto procedure.Among them, 137 knees , 126 patients were included in this study.The patients were grouped into three groups.Group a (n = 46 knees) with 43 patients (34 females, 9 males) age 59.6 ± 7.8 years, gap was filled by ¿-tcp ( chronos® wedge, semicircular; synthes, solothurn, switzerland); group b (n = 48 knees) with 43 patients (34 females,9 males) age 61.5 ± 7.6 years, no gap fillers; and group c (n = 43 knees) with 40 patients (32 females, 8 males) age 60.7 ± 9.3 years, gap filled with ¿-tcp and autologous cancellous bone graft obtained from the ipsilateral medial femoral condyle.The osteotomy was stabilized using a tomofix¿ plate(synthes, oberdorf, switzerland).The patients were followed-up at a mean period of 22 months (ranging from 13 to 49 months).The following complications were reported as follows: 1 patient died who was excluded in the study.(group b).Delayed union: 26 in group a , 20 in group b and 1 in group c.The incidence of lateral cortical hinge fracture was similar in all three groups.Post-operative lateral cortical fracture: 7 in group a, 5 in group b and 9 in group c.Infection: 1 in group a, and 2 in group b.Fig.4 six-month postoperative x-rays and ct scan of (b)(6)-year old female who underwent bilateral mow-hto.X-rays show sclerotic rim in left knee which is absent in right.Ct scan shows the absence of bridging callus formation in left knee.This report is for an unknown synthes chronos® and tomofix¿ plate.
 
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Brand Name
UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA
Type of Device
FILLER, BONE VOID, CALCIUM COMPOUND
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 Key11148973
MDR Text Key230225815
Report Number8030965-2021-00215
Device Sequence Number1
Product Code MQV
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Physician
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2020
Initial Date FDA Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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