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); Granuloma (1876); Failure of Implant (1924)

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.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 (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 6 of 9 for (b)(4).Additional reports are captured under (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.H3, h6: customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition is unconfirmed as the picture did not show any loosening issues with the screws.As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image(s) provided.There is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11635272
• MDR Text Key: 261921954
• Report Number: 8030965-2021-02720
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• PMA/PMN Number: K121574
• 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: 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
• Date Manufacturer Received: 04/26/2021
• Patient Sequence Number: 1
• Treatment: MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; MATMAND SCR Ø2 SELF-TAP L6 FINE-PITCH TH; TRUMATCH MIDFACE/MANDIBLE TI PL
• Patient Outcome(s): Required Intervention