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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an even in (b)(6) as follows: it was reported that a patient initially underwent a cranial cradle implant procedure on (b)(6) 2014.A second procedure was performed on (b)(6) 2014 under suspicion of cranial cradle dislocation.None was found intra-operatively, so the procedure was for lengthening only.According to x-ray images taken on (b)(6) 2014, the cranial cradle was found to be jutted out at the proximal region on the left side with a possibility of dislocation.The surgeon replaced the cranial cradle with a veptr ii device during an operation on (b)(6) 2015.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

This report for an unknown veptr device.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.Device 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 (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4730606
• MDR Text Key: 5705241
• Report Number: 2520274-2015-13434
• 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: 04/07/2015

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 04/27/2015
• 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: 10 YR