MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-8PLATES; IMPLANT

Model Number 78-92008

Device Problem Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

It was reported that the patient had broken facial id plates removed and replaced.There were no adverse consequences reported.

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.Device not available.

Manufacturer Narrative

The reported event could be confirmed: the returned plates show fractures.Three plates of the set under complaint were returned in order to determine the root cause of the failure.The samples were examined regarding its dimensions, chemical composition (edx analysis) and by light and scanning electron microscopy.The (measurable) dimensions are in accordance with the specification.The chemical composition of all three plates conform to the specification titanium grade 3.The macroscopic appearances of all three plates point to exceeding the material strength.That is confirmed by the deterioration of the anodization layer, the changes of the surface¿s structure, and the secondary cracks in the area of the breakages.The fracture surfaces were partially and / or totally leveled due to friction with the counterpart.The undestroyed fracture surfaces (rest) show the appearance of a low cycle fatigue rupture.The fractographic investigations with sem show a structure of a low cycle fatigue rupture with secondary cracks and in addition, swinging lines of a fatigue breakages are visible.The further provided information did not show any deviation from the user¿s instructions.All relevant quality documents (manufacturing and inspection documents) have been reviewed.The device history records for catalog # 78-92008 and lot code # 2008141014 indicate (b)(4) was manufactured, accepted into final stock on 2020-aug-28.No issues could be found in the manufacturing or inspection documents.Based on the investigation and the corresponding statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no corrective and / or preventive actions are deemed necessary at this time.

Event Description

It was reported that the patient had broken facial id plates removed and replaced.There were no adverse consequences reported.

• Brand Name: FACIAL ID-ORTHOG-8PLATES
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13052590
• MDR Text Key: 286857982
• Report Number: 0008010177-2021-00056
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07613327370881
• UDI-Public: 07613327370881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 78-92008
• Device Catalogue Number: 78-92008
• Device Lot Number: 200814101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention