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

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was detected on (b)(6) 2015 during a routine check-up that the proximal cradle in question jutted out at the proximal part on right side.On (b)(6) 2015, the replacement surgery took place applied with vertical expandable prosthetic titanium rib (veptr) ii.The initial implant date was on (b)(6) 2013.The veptr system was implanted on the sixth rib to the ilium (right side).The surgeon commented the mechanism of veptr which cradle needs to be hooked on rib might be one of the factors of this event.This complaint is for one unknown veptr system.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Unknown when device jutted.Report is for one unknown veptr device.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.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: 4864883
• MDR Text Key: 5810750
• Report Number: 2520274-2015-14613
• Device Sequence Number: 1
• Product Code: MDI
• 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,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• 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?: Yes
• Date Manufacturer Received: 06/11/2015
• 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: 11 YR