MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MANDIBULAR FRACTURE PLATE, 6-HOLES, 140° ANGLED; IMPLANT

Model Number	55-15536
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device implanted in patient.
Event or Problem Description
It was reported that a patient had mandible plates break while eating.Scan for revision surgery planned.
Additional Manufacturer Narrative
As described in the event description, the plate broke while the patient was eating.The plate breakage could be confirmed as an image was provided for review.At the time this event was reported, the plate was in service for 40 days.Correspondence has shown that the surgeon saw the patient on (b)(6) 2022.The mandible is stable and healing.Surgeon will not revise but will monitor patient¿s healing.It is unknown whether the patient was compliant to post-care instructions.This complaint was forwarded to stryker¿s medical expert for evaluation.He stated that " the plate seems to have been used and implanted appropriately.¿ based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.Therefore, no further corrective and / or preventive actions are deemed necessary at this time.
Event or Problem Description
It was reported that a patient had mandible plates break while eating.Scan for revision surgery planned.

• Brand Name: MANDIBULAR FRACTURE PLATE, 6-HOLES, 140° ANGLED
• 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: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 13228272
• Report Number: 0008010177-2022-00003
• Device Sequence Number: 4164423
• Product Code: JEY
• UDI-Device Identifier: 04546540356345
• UDI-Public: 04546540356345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K014263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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
• Operator of Device: Other
• Device Model Number: 55-15536
• Device Catalogue Number: 55-15536
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 04/18/2022
• 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