MAUDE Adverse Event Report: SYNTHES USA UNKNOWN - SCREW MATRIXMANDIBLE; SCREW FIXATION INTRAOSSEOUS

Device Problem Unintended Movement (3026)

Patient Problems Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Date of device loosening and infection is unknown.Report is for unknown screw, unknown part, unknown lot.Device not available for return (b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.

Event Description

It was reported that patient had a revision surgery on (b)(6) 2016 for an oral fistula and post op infection.A female patient had a calcifying epithelial odontogenic tumor and was implanted with a plate and six 2.4 matrix mandible locking screws on (b)(6) 2016.At the time of the revision it was found that the plate and screws seemed to be loosening, all hardware was removed and fully intact.No new product was implanted, surgeon wanted patient to heal.Patient will be implanted with new hardware at a later date.There was no delay in removal surgery.Patient's outcome is good.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Quantity 6 for unknown screws.

• Brand Name: UNKNOWN - SCREW MATRIXMANDIBLE
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5950290
• MDR Text Key: 54696051
• Report Number: 2520274-2016-14532
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• 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