MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG MANDIBULAR FRACTURE PLATE, 14-HOLES; IMPLANT

Model Number	55-15514
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation, and no explanation was provided.Device not available to stryker for evaluation, and no explanation was provided.
Event or Problem Description
It was reported by a company representative that a patient developed a possible post-surgical infection over a month after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but a revision surgery occurred to remove the plate.There have been no issues found since then.
Event or Problem Description
It was reported by a company representative that a patient developed a possible post-surgical infection over a month after initial implantation with an implant.The original procedure was reported as completed successfully without a delay, but a revision surgery occurred to remove the plate.There have been no issues found since then.
Additional Manufacturer Narrative
The devices were not returned for evaluation nor any infection documents (e.G.Laboratory test results) have been received.Thus, the reported event could not be confirmed.Further information has been requested regarding the reported event.No further details to the screws (i.E.Catalog numbers) could be provided.As described in the event description, the patient had inquired an infection 3 weeks post surgery and had been treated with antibiotics.However, as patient is non-compliant to post operative care instructions, surgeon had to perform revision surgery on (b)(6) 2020.Patient is reported to be doing well.Sales rep also stated that the surgeon does not know whether infection was due to non-compliance of the patient or the loosening of the device.Infection is a known adverse event related to this procedure.It has been documented in the instructions for use associated with this device that this type of adverse event may rather be clinically related than implant related.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.The complaint is added to the complaint trend.Should further information be available, the investigation will be re-evaluated.H3 other text : product not available for return.

• Brand Name: MANDIBULAR FRACTURE PLATE, 14-HOLES
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 9913453
• Report Number: 0008010177-2020-00020
• Device Sequence Number: 2817744
• Product Code: JEY
• UDI-Device Identifier: 04546540356314
• UDI-Public: 04546540356314
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/13/2021

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: Health Professional
• Device Model Number: 55-15514
• Device Catalogue Number: 55-15514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 2.0 SCREW
• Outcome Attributed to Adverse Event: Required Intervention