MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING PLATE, SAGITTAL SPLIT, 12MM BAR, 6 HOLE, ORTHIOGNATHIC; IMPLANT

Model Number	55-10556
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
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.
Event or Problem Description
It was reported by the healthcare professional that it was noticed 1 year post operative, that the plate implanted was broken.No other information is known at this time.
Event or Problem Description
It was reported by the healthcare professional that it was noticed 1 year post operative, that the plate implanted was broken.No other information is known at this time.
Additional Manufacturer Narrative
Images were received that show the devices after initial implantation and during the plate breakage.Initially, only one plate was reported to be broken.However, a review of the post-operative x-ray during the investigation has revealed that both plates are broken.In the post-op image, it could be observed that bone healing had been achieved even though the plates are broken.It was mentioned that the patient had followed post-op care instructions and grinding was not observed.The devices will be removed at an unknown date.This case was presented to stryker¿s medical expert.He stated that ¿(¿) the plates should be intact 1 year after surgery, but there are no adverse events from a plate fracture after adequate bone healing (after 3 months following surgery) (¿)¿ except for the planned plate removal, no adverse consequences were reported for this event.Based on the performed statistical investigation, there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Should the devices be returned, or further information be available, the investigation will be re-evaluated.H3 other text: device is still implanted.

• Brand Name: LOCKING PLATE, SAGITTAL SPLIT, 12MM BAR, 6 HOLE, ORTHIOGNATHIC
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11689581
• Report Number: 0008010177-2021-00020
• Device Sequence Number: 3121855
• Product Code: JEY
• UDI-Device Identifier: 04546540366252
• UDI-Public: 04546540366252
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 06/11/2021

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: 55-10556
• Device Catalogue Number: 55-10556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention