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

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Common device name: stabilization or correction of spinal deformities without the use of fusion.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2015: the device was implanted in patient.On (b)(6) 2016: the patient presented for follow-up visit at 18 months ¿ no issues found radiographically (b)(6) 2016: the patient fell off a jungle gym and hit hard on the right shoulder.For complaint of pain, the patient saw a doctor in the neighborhood and was diagnosed with fracture at right shoulder under radiographic images.On (b)(6) 2016: the patient underwent radiographic exam and no loosening or migration of implant was observed.The patient also did not complaint of peri-implant pain.On (b)(6) 2017: the patient presented for follow-up visit at 24 months.The patient underwent radiographic exam in which rod fracture was observed in the left-side t11-12.The patient's family told that incident which might result in the rod fracture was not noticed (after previous visit).Until today, the patient has not complained of numbness or pain at the site.On (b)(6) 2017: re-operation is planned to replace the implant.

Manufacturer Narrative

Additional information: image review: "long segment thoraco lumbar fixation shows a paucity of hardware at intervening thoracic level with an expected rod fracture at the thoraco lumbar junction.The rods also extend well beyond the vertebral instrumentation.Unable to assess bony fusion.Root cause:surgical technique.".

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6434952
• MDR Text Key: 70860544
• Report Number: 1030489-2017-00599
• Device Sequence Number: 1
• Product Code: PGM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2017
• 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): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 31