MAUDE Adverse Event Report: SYNTHES USA

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

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Device report received from synthes (b)(4) reports an event in (b)(6) as follows: patient was implanted with vertical expandable prosthetic titanium rib (veptr) on (b)(6) 2013.Post implant, the patient fell often.On a follow-up visit on (b)(6) 2013 the doctor suspected a case of separation of the proximal cradle.X-ray taken on (b)(6) 2013 showed the cradle separating.The patient was returned to the operating room on (b)(6) 2013 for revision.The third and fourth ribs on the left side were broken.The patient was revised from the fifth rib along with the sixth rib to the third lumbar spine in order to increase the intensity of the orthodontic force of the veptr and to keep the stability of the cradle.The surgeon felt a possible cause was due to the patient¿s bone being fragile and the patient falling often after the surgery.This report is for an unknown veptr cradle.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis report is for an unknown veptr device, quantity 1.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

Manufacturer Narrative

Device used for treatment, not diagnosis.

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3562561
• MDR Text Key: 4060372
• Report Number: 2520274-2014-00126
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2013

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: 01/08/2014
• Initial Date FDA Received: 01/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 20