MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM; BONE PLATE

Catalog Number 04.511.206.01C

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The screw delivered from synthes to customer (through materialise) are all delivered in an unsterile condition.Based on this no investigation will be done on those from synthes side.We have forwarded the received information to the legal manufacturer materialise for investigation, find the statement below: results + date: for this complaint, the design and manufacturing aspects were investigated.The bsso plates were designed according to the work instructions.The measurements taken to control the planning aspects were all within the specifications.As such the position of the plate was planned correctly.The implant design also met specifications as the thickness and with were according to the work instructions.The screws were placed more than 3.5mm apart from each other and therefore this part of the design also met specifications.The mechanical aspects of the design were also investigated.It was found that the dimensions and mechanical properties of the bsso plates were according to design and specifications.No changes were found that could influence design or biocompatibility of the devices.Infections can occur due to non-device related reasons such as inadequate wound closure (originally indicated by surgeon).However, this cannot be confirmed nor excluded based on the available information and it does not explain the other infection complaints.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, the patient experienced infection on the right side of the mandible.Initially, the patient had a sagittal split osteotomy with a tumatch midface/mandible plate and an unknown screws on an unknown date.It was unknown if there will be a plan revision surgery.Patient status is unknown.This report is for one (1) 1.85mm ti matrix screw self-tapping/6mm.This is report 4 of 6 for (b)(4).

• Brand Name: 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8676112
• MDR Text Key: 147319485
• Report Number: 8030965-2019-65004
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819358140
• UDI-Public: (01)07611819358140
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.206.01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2019
• 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