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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Injury (2348)

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 a patient operated on in january has a discolored tooth (tooth #32).Patient underwent bimaxillary osteotomy with genioplasty.The surgeon suspects one of the screws in the patient¿s genioplasty plate is too close to the tooth root.The surgeon has post-op ct scans and is ordering a 6 month follow up ct scan.This report is for a 1.85mm titanium (ti) matrix screw.This is report 1 of 1 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10455369
• MDR Text Key: 204552320
• Report Number: 8030965-2020-06330
• 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: Physician
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/26/2020
• 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