MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-1PLATE; IMPLANT

Model Number	78-92001
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	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, it was noticed the plates did not fit as expected.The plate was not used to complete the surgery however, there was a stock plate available to successfully complete the surgery.There were no adverse consequence reported and no significant surgery delay.
Additional 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.
Event or Problem Description
It was reported that during the surgery, it was noticed the plates did not fit as expected.The plate was not used to complete the surgery however, there was a stock plate available to successfully complete the surgery.There were no adverse consequence reported and no significant surgery delay.
Additional Manufacturer Narrative
Update: h6: the reported event could not be confirmed.The case was planned as a 3-piece lefort i surgery with a large anterior movement of 9-10 mm.The sales rep reported that the advancement of the plate was too big, and using the plate would have advanced the maxilla to far forward.Thus, the plate was not used, and stock plates were bent and used instead, which extended the surgery time by 30-40 minutes.The guides were used, but predicted holes could not be used in conjunction with the stock plates.No post-op ct is available.A complaint analysis was performed by stryker¿s custom design team.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.Additionally, the pictures of the fit test of the maxillary plate, which is performed after manufacturing at stryker, were reviewed, and showed a good fit of the plate to the bone model.Overall, no discrepancy was found throughout the design process.In conclusion, the plate was designed according to the data transmitted by 3d systems and manufactured according to specification.No device problem related to the plates on stryker¿s end could be found.The pictures of the fit test, which is performed during manufacturing at stryker, were reviewed, and showed a good fit of the plate to the bone model.

• Brand Name: FACIAL ID-ORTHOG-1PLATE
• 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: 17325416
• Report Number: 0008010177-2023-00049
• Device Sequence Number: 6319249
• Product Code: JEY
• UDI-Device Identifier: 07613327370782
• UDI-Public: 07613327370782
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/25/2023

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: 78-92001
• Device Catalogue Number: 78-92001
• Device Lot Number: 2305241020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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