MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING PLATE, CURVED, 8 HOLE, MIDFACE; IMPLANT

Model Number	55-05758
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Erythema (1840); Foreign Body Reaction (1868); Fluid Discharge (2686)
Date of Event	07/03/2020
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.Two plates with the same lot number were used in this event; they are both being represented through this medical device report.
Event or Problem Description
The patient had a mandibular fracture, and two plates and their associated bone screws were used during the procedure.Post-operatively the patient presented repeated submental redness and exudation, and showed no significant improvement after 1 month of treatment with anti-inflammatory medications and local dressing changes.As a result, the patient had the plates and screws explanted.There is no indication that the implants did not act as intended.
Event or Problem Description
The patient had a mandibular fracture, and two plates and their associated bone screws were used during the procedure.Post-operatively the patient presented repeated submental redness and exudation, and showed no significant improvement after 1 month of treatment with anti-inflammatory medications and local dressing changes.As a result, the patient had the plates and screws explanted.There is no indication that the implants did not act as intended.
Additional Manufacturer Narrative
The devices were not returned for investigation nor any documents (e.G.Lab results for the alleged titanium) were received for investigation that could confirm the reported event.Upon review of the reported devices, it should be noted that the implants are from different modules and are not intended to be used in combination with each other.In a follow-up, it was mentioned that the alleged titanium rejection appeared after a month post-operatively.Patient received anti-inflammatory treatment.The location of the observed redness and discharge was at the surgical site.Samples from the reported discharge from the surgical site was not taken for laboratory analysis.Further, allergy tests to determine if patient is suffering from titanium rejection were not conducted.However, surgeon stated that the event is a non-infectious inflammation and is negative for bacterial culture.Implants were removed on (b)(6) 2020, as no improvement was seen with regards to patient¿s condition.After implant removal, patient¿s mouth is healed.This event was presented to stryker¿s medical expert.He stated that ¿based on the report of symptoms, this does not appear to be a hypersensitivity reaction to the titanium, rather it appears to be an infection.¿ in sum, the reported event could not be confirmed, nor a root cause could be established as the received information from the customer is insufficient.Based on statistical evaluation there is no indication for an incorrectly working product or any systematic design, material or manufacturing related issue.

• Brand Name: LOCKING PLATE, CURVED, 8 HOLE, MIDFACE
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10896698
• Report Number: 0008010177-2020-00061
• Device Sequence Number: 11430743
• Product Code: JEY
• UDI-Device Identifier: 04546540365682
• UDI-Public: 04546540365682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 55-05758
• Device Catalogue Number: 55-05758
• Device Lot Number: 1000300914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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