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

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).

• 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 Key: 15184012
• MDR Text Key: 297439641
• Report Number: 8030965-2022-05634
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819385849
• UDI-Public: (01)07611819385849
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070843
• Number of Events Reported: 1
• 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 Number: 04.511.970S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention