MAUDE Adverse Event Report: SYNTHES USA; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported during a webex discussion regarding a study related to variable angle (va) condylar plate/screw connection strength that an unknown quantity of screws loosened from a condylar plate.The event was discovered on an unknown date at hershey medical center.This report is for an unknown quantity of unknown locking screws.A partial part number of 02.231.Xxx was provided.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Event date: unknown.This report is for an unknown quantity of unknown locking screws.A partial part number of 02.231.Xxx was provided.Additional product codes for this report include: hrs and hwc.Implant/explant: unknown.Based off of the partial part number for this complainant part, the likely 510k number is k110354.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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.

• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4808593
• MDR Text Key: 5894631
• Report Number: 2520274-2015-14126
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• 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: 05/08/2015
• 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