MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK SHILLA GROWTH GUIDANCE SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that 33 patients underwent unspecified instrumentation surgery, for the treatment of early-onset scoliosis (neuromuscular, idiopathic, congenital, syndromic).Post-operatively, spinal alignment issues were seen in eight patients: six had progression of the curve (>15°) and two had progression of pelvic obliquity.Reportedly, five of the eight were skeletally mature enough to undergo a definitive fusion; one underwent extension of the instrumentation to the pelvis, and one underwent replacement with dual growing rods (patient had a double major curve).One underwent correction of his curvature with implant revision.No further information was provided.

• Brand Name: SHILLA GROWTH GUIDANCE SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6002410
• MDR Text Key: 56539203
• Report Number: 1030489-2016-02784
• Device Sequence Number: 1
• Product Code: PGM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention