MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, RIB REPLACEMENT

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

Patient Problem Pneumothorax (2012)

Event Date 01/27/2014

Event Type  Injury  

Event Description

It was reported that during the implant surgery of a veptr-ii implant and an unknown amount of universal spine system dual opening screws on (b)(6) 2014, the patient developed a right sided pneumothorax.The patient was treated with an insertion of a twelve-french chest tube for four days.The procedure was completed successfully.The product was not explanted from the patient.The patient was discharged on (b)(6) 2014 without further complications.During a follow up on (b)(6) 2014, the patient was clear of complications.This report is for one unknown veptr-ii implant.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

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.This report is for 1 unknown veptr-ii implant/unknown lot.Explant date: product was not explanted.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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: 3671299
• MDR Text Key: 4321426
• Report Number: 2520274-2014-10193
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• 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
• Date Manufacturer Received: 02/18/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 7 YR