MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-2PLATES; IMPLANT

Model Number 78-92002

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device implanted in patient.

Event Description

It was reported that the facial id chin plate was manufactured with the incorrect system for the procedure.The surgeon required a 2.0mm thick mini plate but the plate was 1.7mm thick.The procedure was completed successfully and no adverse consequences were reported.

Manufacturer Narrative

The reported event could be confirmed according to the manufacturing documentation and the design specifications in the design proposal.The case was a 1-piece lefort i surgery, a bsso, and a genioplasty with a mandibular symphyseal split osteotomy.For this plate the anatomical region was chosen to be the chin area with the 1.7 mm screw system and a profile height of 1.0 mm, which is only approved for pure genioplasty.Due to the additional mandibular symphyseal split of the chin, the application of the plate should have been changed to mandible application, which requires either the 2.0 mm mp or the 2.0/2.3 mm screw system and at least a profile height of 1.2 mm.The manufacturing documentation and the design proposal confirmed that the plate was designed and manufactured with the 1.7 mm screw system and with a profile height of 1.0 mm.The planning of this case including the selection of the screw system was performed by 3d systems per stryker procedure.The design of the plate was finalized by stryker and the incorrectly selected screw system not identified.

Event Description

It was reported that the facial id chin plate was manufactured with the incorrect system for the procedure.The surgeon required a 2.0mm thick mini plate but the plate was 1.7mm thick.The procedure was completed successfully and no adverse consequences were reported.

• Brand Name: FACIAL ID-ORTHOG-2PLATES
• 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: 13549031
• MDR Text Key: 289222782
• Report Number: 0008010177-2022-00006
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K182305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 78-92002
• Device Catalogue Number: 78-92002
• Device Lot Number: 2112221025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 20 YR