MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: CMF; PLATE,FIXATION,BONE

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown plate: cmf/unknown lot.Part and lot numbers 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure, the shapes on the mandibular jaw model and the unknown custom-made plate did not match each other.The procedure was successfully completed.The patient outcome was stable.This report is for one (1) unk.Plates: cmf.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - PLATES: CMF
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10984311
• MDR Text Key: 220970554
• Report Number: 8030965-2020-09568
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1