MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.206.01C

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: only event year is known.Additional device product codes: jey.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).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 reports an event in (b)(6) as follows: it was reported that on an unknown date, that a patient experienced post-op infection with pus in the place where the implant was placed three (3) weeks ago.The reported date of implant was (b)(6) 2020.The date of explant was (b)(6) 2020.Concomitant devices reported: ti matrixmidface screw self-tapping 6mm (part number 04.503.206.01c, lot unknown, quantity 5).This report involves one (1) ti matrixmidface screw self-tapping 6mm.This is report 4 of 6 for (b)(4).This product complaint, (b)(4), is related to (b)(4).(b)(4) capture the post op event due to infection, while (b)(4) captures the intra op event which involved two (2) broken screws.

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.A1: additional patient identifier: (b)(6).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: TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10612934
• MDR Text Key: 209379105
• Report Number: 8030965-2020-07605
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908376
• UDI-Public: (01)07611819908376
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.206.01C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Patient Sequence Number: 1
• Treatment: TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM; TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR