MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screws: trauma/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Investigation summary: 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.Without a lot number the device history records review could not be completed.Product was not returned.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 during the osteotomy surgery for maxillary and mandibular on (b)(6) 2019 via le fort i.It was confirmed some screws which inserted at maxillary were loose on (b)(6) 2019, the revision surgery was performed on the same day.Doctor comments: although 9 screws were loose, there was no problem with the product.Patient outcome was stable after revision surgery.Concomitant devices reported: unknown plate (part# unknown, lot # unknown, quantity 1), unknown screws (part # unknown, lot # unknown, quantity# 9).This is report 3 of 9 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9451468
• MDR Text Key: 170419859
• Report Number: 8030965-2019-71019
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2019
• 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