MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM; PLATE, BONE

Catalog Number 04.503.556.01C

Device Problem Device Slipped (1584)

Patient Problems Wound Dehiscence (1154); Bruxism (4427)

Event Type  Injury  

Manufacturer Narrative

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 (b)(6) reports an event as follows: it was reported that patient developed anterior open bite (aob) despite physician checking bite after operation and being satisfied and despite strength of plates and use of mandibulomaxillary fixation (mmf) and muscle relaxants to stop clenching behavior related to obstructive sleep apnea (osa).Positive remediation of osa but residual occlusal malalignment.Found eight months post op with poor oral hygiene and dehiscence over mandible bsso plates.Le fort plate and maxilla position are stable, as is the genioplasty plate and chin position; however, physician suspects micro movements of mandible plates and screws due to extreme physiological loading, grinding, and insistence on chewing during purée time zone (8 weeks according to protocol).Physician does not believe this is related to implant technology but likely related to patient related factors.Screws were loose in the mandible.Granulation tissue present.Local bone sequestra may be contributing factor.Osteotomy solid.Revision surgery was performed; surgeon routinely removes all hardware.This report is for a 2.0mm ti matrixmandible screw fine pitch / 6mm.This is report 7 of 9 for (b)(4).Additional reports are captured under pc (b)(4).And pc (b)(4).

• Brand Name: 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM
• Type of Device: PLATE, BONE
• 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: 11635380
• MDR Text Key: 261665018
• Report Number: 8030965-2021-02724
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819516748
• UDI-Public: (01)07611819516748
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121574
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.556.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• 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