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

Model Number	78-92002
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : implanted.
Event or Problem Description
It was reported that during the surgery the surgeon found the plate did not fit well against the bone.When a screw was placed, the plate would come off the bone.The surgery was completed successfully and no reported adverse event.
Event or Problem Description
It was reported that during the surgery the surgeon found the plate did not fit well against the bone.When a screw was placed, the plate would come off the bone.The surgery was completed successfully and no reported adverse event.
Additional Manufacturer Narrative
Update: h4, h6 the reported event could not be confirmed as no intra-operative photo was provided.Further info was provided by the sales rep including a sketch of the issue with the left maxillary plate.He stated that, when a screw was fixated medially into the plate, the plate would come off the bone laterally.The plate was used overall with a short delay of 1-2 minutes.A complaint analysis was performed by stryker¿s custom design team regarding the fit issue of the left maxilla plate.An overlay of the plates, which were manufactured by stryker, and the plates as planned by 3d systems was performed.The designs are consistent with each other.The segmentation was reviewed by stryker and found that the segmented anatomy in the area of the lateral fixation points of the plate appears rough.If those areas were over-segmented, this could have contributed to the observed lift of the plate.Since the segmentation was performed by 3d systems, further investigation is performed in complaint (b)(4), by 3d systems.In conclusion, the plate was designed according to the data transmitted by 3d systems and manufactured according to specification.H3 other text : implanted.

• Brand Name: FACIAL ID-ORTHOG-2PLATES
• Common Device Name: 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 17221623
• Report Number: 0008010177-2023-00047
• Device Sequence Number: 20386925
• Product Code: JEY
• UDI-Device Identifier: 07613327370935
• UDI-Public: 07613327370935
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 78-92002
• Device Catalogue Number: 78-92002
• Device Lot Number: 2305051002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown