MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.228.01C

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional product code: jey.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)(6) reports an event as follows: patient had a palatal fracture fixation on (b)(6) 2021.Patient informed the surgeon on (b)(6) 2021 that he accidentally swallowed a screw as it came loose from the fixation.The screw is likely an 8mm matrix midface 1.5mm diameter self-drilling screw.An x-ray of the abdomen was done on (b)(6) 2021; no screw was found.Patient did not experience any discomfort.This report is for a diameter self-drilling screw.This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12253334
• MDR Text Key: 264321361
• Report Number: 8030965-2021-06266
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908604
• UDI-Public: (01)07611819908604
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.228.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• 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
• Patient Outcome(s): Required Intervention