MAUDE Adverse Event Report: SYNTHES GMBH TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM THICK; PLATE, BONE

Model Number SD480.110

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Device report from japan reports an event as follows: it was reported that prior to a mandibular reconstruction procedure on 22-june-2022, it was confirmed by the surgeon that the custom-made devices did not conform to the patient¿s ct data.No further information is available.This report is for a ti patient specific plate mandible/angle/2.0mm thick.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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 expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Manufacturer Narrative

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.H10 additional narrative: a manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Product code : sd480.110.Lot number : 871p415.Manufacturing site: mezzovico.Release to warehouse date: 07 jun 2022.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI PATIENT SPECIFIC PLATE MANDIBLE/ANGLE/2.0MM THICK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO; via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15040995
• MDR Text Key: 303943026
• Report Number: 8030965-2022-04919
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587005324
• UDI-Public: (01)10887587005324
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD480.110
• Device Catalogue Number: SD480.110
• Device Lot Number: 871P415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PS INSTR/PLAN KT MANDBL RECON; PS INSTR/PLAN KT MANDBL RECON