MAUDE Adverse Event Report: SYNTHES USA TI MULTI VECTOR DISTRACTOR BODY; SCREW FIXATION, INTRAOSSEOUS

Catalog Number 487.931

Device Problems Failure to Advance (2524); Unintended Movement (3026)

Patient Problems Airway Obstruction (1699); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that there was a failure in advancement of a distractor from a planned bilateral mandibular distraction involving a neonate with pierre-robin sequence.The distractor was implanted on (b)(6) 2015 and there were no surgical delays reported.However, it was noted that there was a question as to whether the surgeon was able to complete the ostomy on the one side.When the patient was examined on (b)(6) 2015, the surgeon felt that the patient was not getting advancement and decided to make a mark on the distractor.Later that day, a second physician came in to check on the patient and noticed that the distractor had moved backwards.A decision was made to lock down the distractor so it would not reverse, therefore continuing with distraction.According to the physician, they were able to successfully obtain the advancement by activating then locking the distractor down.The second part of the procedure will be done very shortly (in approximately 6 weeks) and will entail the consolidation of rods.It was noted that there is the potential for an incomplete osteotomy.This report is 3 of 11 for (b)(4).

Manufacturer Narrative

Unknown patient information.Event date: unknown - date of post-operative non-advancement and distractor movement is unknown.Device has not been explanted; additional procedures where the device may be removed are to come.Complainant part is expected to be returned for manufacturer¿s review/investigation, but has yet to be received.(unintended movement) was included to reflect the backwards movement of the distractor as noted by the physician.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/completed.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.

Manufacturer Narrative

(b)(4): five (5) component parts were removed during the revision procedure on (b)(6), 2015; it is unknown which of the 11 involved parts were explanted.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.

Event Description

Update: it was reported that the second part of the procedure was completed on (b)(6), 2015.Five components were removed to put on consolidation rods.It was reported that after the consolidation rods were put on, the patient had to come back to surgery due to a decreased airway.New distractors had to be put on to continue distraction.

• Brand Name: TI MULTI VECTOR DISTRACTOR BODY
• Type of Device: SCREW FIXATION, INTRAOSSEOUS
• 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: 4482709
• MDR Text Key: 18892772
• Report Number: 2520274-2015-10753
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 487.931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• 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
• Patient Outcome(s): Required Intervention