MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING PLATE, SAGITTAL SPLIT, 6MM BAR, 6 HOLE, ORTHIOGNATHIC; IMPLANT

Model Number	55-10554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
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 has been reported that the patient had experienced a plate breakage postoperatively.Due to the plate breakage, a revision surgery will be performed to explant the plate.
Additional Manufacturer Narrative
The reported event ¿breakage - postoperative¿ could not be confirmed, because the revision date for the removal of the plate is still unknown and no pictures (e.G.X-rays, ct-scans) of the broken plate could be provided after several requests.Nevertheless, it has been reported that 52-20404 and 52-20504 (screws) have been used in combination with the plate under complaint.These screws are part of the universal mandible system as the plate.Thus, these are intended to be applied together.Limited information was provided by the sales rep as the sales rep could not meet with the customer and he also mentioned that the customer stopped responding to his emails.Based on the performed statistical investigation, 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 that time.The complaint is added to the complaint trend.Should the device be returned, or further information be available, the investigation will be re-evaluated.H3 other text : revision date for removal unknown.
Event or Problem Description
It has been reported that the patient had experienced a plate breakage postoperatively.Due to the plate breakage, a revision surgery will be performed to explant the plate.

• Brand Name: LOCKING PLATE, SAGITTAL SPLIT, 6MM BAR, 6 HOLE, ORTHIOGNATHIC
• 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: 12540777
• Report Number: 0008010177-2021-00043
• Device Sequence Number: 19110719
• Product Code: JEY
• UDI-Device Identifier: 04546540366245
• UDI-Public: 04546540366245
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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?: No
• Device Model Number: 55-10554
• Device Catalogue Number: 55-10554
• Device Lot Number: 1000451948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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