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

Model Number	55-15536
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Pain (1994)
Date of Event	05/26/2020
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 was not returned from facility.
Event or Problem Description
It was reported that the patient was treated for a fractured jaw.Post-operatively the patient presented with possible infection (pain, abcess) on right parasymphysis area.The surgeon removed the hardware on parasymphysis but did not re-plate as the fracture appeared healed.Following this procedure, the patient presented with pain and had a non-union and was brought back in for fixation of parasymphysis.There was no sign of infection at the time of re-fixating patient's jaw.This record pertains to the plate that was implanted.
Event or Problem Description
It was reported that the patient was treated for a fractured jaw.Post-operatively the patient presented with possible infection (pain, abcess) on right parasymphysis area.The surgeon removed the hardware on parasymphysis but did not re-plate as the fracture appeared healed.Following this procedure, the patient presented with pain and had a non-union and was brought back in for fixation of parasymphysis.There was no sign of infection at the time of re-fixating patient's jaw.This record pertains to the plate that was implanted.
Additional Manufacturer Narrative
The devices were not returned for evaluation and infection documents (i.E.Laboratory test results) have not been received.Thus, the reported event could not be confirmed.The infections checklist (cmfqf_13-003) has been filled-out by the sales rep.A review of the document has shown that the type of microorganism is unknown.No further relevant information could be obtained.It has been reported that the patient had an infection (pain,abscess) 5 weeks post operatively.Upon removal of the implants, the surgeon has stated that ¿pt¿s mandible frx looked good at the time of hardware removal.In the related instructions for use (90-01939, rev.8, 2018-oct-18) it is stated that bony healing could be achieved in about 6-10 weeks.Bony healing may have not been attained at the time the surgeon removed the implants due to infection.The patient reportedly came in two weeks after surgery.Surgeon mentioned that the mandible broke again with no implanted devices from torsional movement.During refixation of the fracture, surgeon has stated that there was no sign of infection.Patient is reported to be doing fine.It was also mentioned that the patient has a history of drug/alcohol abuse.And may likely have influenced the reported event.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.

• 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; DE D-79111
• MDR Report Key: 10173956
• Report Number: 0008010177-2020-00034
• Device Sequence Number: 3600057
• Product Code: JEY
• UDI-Device Identifier: 04546540356345
• UDI-Public: 04546540356345
• 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): 07/31/2020

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
• Operator of Device: Health Professional
• Device Model Number: 55-15536
• Device Catalogue Number: 55-15536
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1