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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH MATRIX LOCK SAGITT-SPLIT PL CURV W/INTER; PLATE, FIXATION, BONE

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SYNTHES GMBH MATRIX LOCK SAGITT-SPLIT PL CURV W/INTER; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 04.511.970S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Postal code (b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.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
Device report from synthes reports an event in japan as follows: an ssro procedure was performed in the mandibular ramus on an unknown date.It passed approximately two months since the ssro that the lesion, where the plate was deployed, started swelling.The patient took ct scanning, and s/he was diagnosed as bone resorption.It was also reported that the hospital encountered three bone resorption cases with the plate from (b)(6) 2022.Through (b)(6) 2022.The surgeon had not experienced such a bone resorption case with the plate until the aforementioned cases in 2022.He has not figured out what triggered the events.No further information is available.This report is for one (1) matrix lock sagitt-split pl curv w/inter.This is report 2 of 4 for complaint (b)(4).
 
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Brand Name
MATRIX LOCK SAGITT-SPLIT PL CURV W/INTER
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 
SZ  
6103142063
MDR Report Key15184012
MDR Text Key297439641
Report Number8030965-2022-05634
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819385849
UDI-Public(01)07611819385849
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
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
Device Catalogue Number04.511.970S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2022
Initial Date FDA Received08/08/2022
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;
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