MAUDE Adverse Event Report: SYNTHES USA TI HALF RING; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.910

Device Problem Difficult to Remove (1528)

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

Event Date 06/06/2014

Event Type  malfunction  

Event Description

It was reported that the surgeon completed a veptr lengthening on the patient first, and then wanted to remove the half-ring that is attached to a veptr ii distal rod inside the patient.The screw head was stripped out and he could not remove it with a screwdriver.The surgeon used a burr to drill out the screw, but it would not come out.The surgeon was able to rotate the half-ring on the rod so that the screw/clamp interface would not be prominent to the patient¿s skin.A 2.5mm hex screw was used with the half-ring.The surgery site was closed and surgery completed.There was a thirty minute delay.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Weight reported as (b)(6).Additional product codes: mni, mnh, kwp, kwq.Explant date: device is still in patient; device has not been explanted.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.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.

• Brand Name: TI HALF RING
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3915661
• MDR Text Key: 4515006
• Report Number: 2520274-2014-12400
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• 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: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• 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 Age: 6 YR
• Patient Weight: 18