MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problems Device Appears to Trigger Rejection (1524); Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Event Description

It was reported that the patient had an infected right mandibular plate that needed to be removed, and a revision surgery was performed.

Event Description

It was reported that the patient had an infected right mandibular plate that needed to be removed, and a revision surgery was performed.

Manufacturer Narrative

Corrected data: device was unable to be returned.The device was 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 (e.G.Catalog and lot number of the device, date the infection was discovered and impact to patient) has been requested several times regarding the event.The ¿infection complaints ¿ checklist customer¿ (b)(4) was not completed by the customer.Initially, the response from the sales rep was, ¿(¿) dr.(b)(6) is not concerned with the infection complaint raised as this happens in 10% of cases and she does not believe that the plate is to blame for this.We started to complete the form but did not make much progress with it as it would require her going back through notes and investigating.(¿)¿.Other questions regarding the event were left unanswered.In another follow-up, the sales rep has clarified that ¿(¿) dr.(b)(6) really isn¿t concerned with the infection as this occurs in 10% of patients and wasn¿t down to the plate.(¿)¿.As the customer has stated that the event (infection) was not related to the reported device, expanded investigations related to manufacturing (e.G.Environmental monitoring, sterilization validations tests) process steps were not performed.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: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 8922463
• MDR Text Key: 155266863
• Report Number: 0008010177-2019-00051
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K922489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention