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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 Arthritis (1723)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown biomaterial - preformed: chronos: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: daghino, w., bistolfi, a., aparato, a., and masse, a.(2019), bioabsorbable implants in foot trauma surgery, injury, vol.50(4), pages s47-s55 (italy).The purpose of this study is to standardize the indications and to suggest guidelines for optimizing the use of bioabsorbable devices in foot trauma surgery.From november 2005 to january 2017, a total of 69 patients were included in the study.These patients were divided into 4 froups; the talar fracture group had an average age of 37.0 years (range 14¿66).One of the patients in this group used a synthetic bone tissue (chronos) to fill a bone gap.The calcaneal fracture group had an average age of 41.9 years (range 19¿66).Implants used were a locking compression plate and screws (synthes).The lisfranc group had an average age of 37.3 years (range 15¿68).4 patients used titanium mini-screws, 2.0 mm and 2.7 mm diameter (synthes).The chopart fracture-dislocation group used were 2.7 mm and 2.4 mm titanium mini-screws (synthes), and a synthetic bone tissue (chronos).The article did not specify which of the devices were being used to capture the following complications: talar fracture group: patient 5: an 18-year-old patient had osteoarthritis.Patient 6: a 60-year-old patient had osteoarthritis.Patient 8: a 31-year-old patient had osteoarthritis.Patient 12: a 66-year-old patient had osteoarthritis.Calcanear fractures group patient 1: a 28-year-old patient had delayed skin closure.Patient 10: a 27-year-old patient had delayed skin closure.Patient 18: a 44-year-old patient had delayed skin closure.Patient 21: a 25-year-old patient had osteoarthritis.Patient 29: a 35-year-old patient had osteoarthritis.Lisfranc group: patient 9: a 47-year-old patient had loss of correction.Patient 10: a 48-year-old patient had delayed skin closure.Patient 11: a 47-year-old patient had osteoarthritis.Patient 13: a 28-year-old patient had osteoarthritis patient 14: a 32-year-old patient had delayed skin closure.This report is for an unknown synthes chronos.It captures the reported patient 6: a 60-year-old patient who had osteoarthritis.This is report 2 of 10 for (b)(4).Additional devices are captured under linked complaint (b)(4).
 
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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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11120366
MDR Text Key230486721
Report Number8030965-2021-00068
Device Sequence Number1
Product Code MQV
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2020
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 12/14/2020
Initial Date FDA Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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