MAUDE Adverse Event Report: SYNTHES GMBH TI PATIENT SPECIFIC PLATE MANDIBLE/DBL-ANGLE/2.5MM THK; PLATE, BONE

Catalog Number SD480.101

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown plates: reconstruction/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.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 (b)(6) as follows: it was reported that on an unknown date, during the procedure the surgeon had difficulty placing the plate.The design of the jaw cutting guides was perfect and the drillings fitted perfectly with the holes in the plate; however, once the plate was placed, the plate protruded about two (2) cm in front of the teeth of the upper arch.The patient had a prognathism, which made it impossible to use the plate.This report involves one (1) unknown plates: reconstruction.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.H4, h6: a device history record (dhr) review was conducted: product code: sd480.101, lot number: 84p7923, manufacturing site: mezzovico, release to warehouse date: 12 jan 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.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

It was further reported that once the plate was in place the patient was excessively prognathic, meaning that the fibula and plate were too advanced in relation with the maxilary bone.Surgeon discarded the plate and used a standard plate instead.The patient did not suffer any injuries or harm.There was a fifteen (15) minutes delay during surgery.The procedure was successfully completed.Patient outcome is reported as successful.This report is for one (1) ti patient specific plate mandible/dbl-angle/2.5mm thk.

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.H3, h6: product code: sd480.101, lot number: 84p7923, manufacturing site: mezzovico, release to warehouse date: january 12, 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Investigation summary: the device was not received.A manufacturing investigation was conducted by legal manufacturer: materialise based on the available product and patient information.Design review: during the investigation the images, segmentation, planning and guide design were reviewed.No issues were found with the segmentation or images.When reviewing the planning, no issues were found.This is to be expected as the mandible reconstruction does not require large changes in position of the bones.When reviewing the guide design, no issues were found.Overall it can be concluded that no issues were found with any device or service from materialise.This is in line with the feedback from the surgeon who said the guides fitted perfectly.Conclusion: the complaint cannot be confirmed for cmd patient specific plate f/mandib matm.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.

• Brand Name: TI PATIENT SPECIFIC PLATE MANDIBLE/DBL-ANGLE/2.5MM THK
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11737103
• MDR Text Key: 248370178
• Report Number: 8030965-2021-03355
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K122647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD480.101
• Device Lot Number: 84P7923
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - SCREWS: TRAUMA