MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG FACIAL ID-ORTHOG-3PLATES; IMPLANT

Model Number	78-92003
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
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 the plate was broken.The patient needed to have the plate removed.There was no further information available.
Additional Manufacturer Narrative
The reported event could be confirmed as the returned plate # 3 of the set (containing 3 plates) was returned broken.The sample was 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 fracture surfaces show the appearance of a forced rupture.Furthermore, there is also strong embrittlement on each fracture surface.The sales rep stated that 2.0/2.3 mandible screws were used in combination with the plate under complaint, which is appropriate.Furthermore, it has been reported that the plate has not been bent and bone healing has not been achieved when the implants were removed.Related to the event in question, a review of additional documentation (x-rays) was performed.The x-ray provided was forwarded to stryker¿s senior global medical director along with the complaint information.He stated that the plate was inserted rotated counterclockwise 10 degrees compared to the design proposal, in which case hole 3 (the fracture side) would not have been flush to the bone.In sum, according to the statement of stryker¿s senior global medical director the plate has been implanted differently as recommended in the design proposal, which led to an improper alignment.As a result, too high forces acted on the plate after implantation which most likely caused the plate breakage and therefore, no bone healing was achieved.
Event or Problem Description
It was reported that the plate was broken.The patient needed to have the plate removed.There was no further information available.

• Brand Name: FACIAL ID-ORTHOG-3PLATES
• 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 ; 76145120
• MDR Report Key: 13595190
• Report Number: 0008010177-2022-00008
• Device Sequence Number: 5848627
• Product Code: JEY
• UDI-Device Identifier: 07613327370775
• UDI-Public: 07613327370775
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 78-92003
• Device Catalogue Number: 78-92003
• Device Lot Number: 2107151011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown