MAUDE Adverse Event Report: KLS-MARTIN L.P.; PLATE, CRANIOPASTY

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/30/2015

Event Type  No Answer Provided  

Event Description

A segmental midface osteotomy and application of midface distraction halo device was performed on the patient.His postoperative course was uneventful.His distraction process was initiated 5 days postoperatively as planned.This protocol included 0.5mm of vertical downward distraction and 1.0 mm of anterior distraction per day.Five days after initiation, the protocol was changed to 1.0mm/day vertical downward distraction and 0.5mm/day anterior distraction.The occlusal plane was also adjusted upward to impart a more anatomic plane.A 1.5mm downward movement was made to offset this adjustment.The patient was readmitted on the next day after an episode of epistaxis at home.He had two subsequent episodes of epistaxis warranting a return to the or to pack the bilateral nasal cavities.The following day the decision was made to continue the distraction process with the packing in place.Following the direction indicated on the activation wrench supplied by the manufacturer for the vertical drive it was noted that an upward movement of the device rather than the intended downward movement resulted.This results in impaction rather than distraction in the vertical dimension.Therefore the distraction device that is designed to move the midface forward and downward was moving the midface forward and upward using the turning cues provided on the device provided.This may have contributed to the patient's bleeding although no source of the bleeding was identified in the or.It is unclear if this caused physical harm to the patient.The patient is in active treatment with the same device with the appropriate vector being applied.

• Type of Device: PLATE, CRANIOPASTY
• Manufacturer (Section D): KLS-MARTIN L.P.; 11201 st. johns industrial par; jacksonville FL 32246
• MDR Report Key: 4938357
• MDR Text Key: 6255651
• Report Number: 4938357
• Device Sequence Number: 1
• Product Code: GXN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2015
• Patient Sequence Number: 1
• Patient Age: 9 YR