MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: MATRIXMIDFACE; SCREW, FIXATION, INTRAOSSEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event date: exact date of event is unknown; event occurred sometime between the original procedure on (b)(6) 2020 and wound secretion discovery on (b)(6) 2020.This report is for an unknown mandible screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event as follows: it was reported that the patient underwent the surgery of internal fixation of a mandibular fracture on (b)(6) 2020.On (b)(6) 2020, the patient was admitted to hospital.Examination of the lower vestibular sulcus showed incision scar, good jaw relationship and strong chewing.A sinus was formed in the submandibular area.A small amount of wound secretion was observed in the submandibular area.On (b)(6) 2020, the patient underwent a maxillofacial bone internal fixation removal surgery under general anesthesia.After removing the plate, the patient's wound secretion was improved.No additional information can be provided.This report is for an unknown mandible screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - SCREWS: MATRIXMIDFACE
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12452903
• MDR Text Key: 270799588
• Report Number: 8030965-2021-07629
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 10/21/2021
• Patient Sequence Number: 1
• Treatment: ADAPTPL 20HO T0.7 TI; ADAPTPL 20HO T0.7 TI
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR