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

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: patient was diagnosed with idiopathic scoliosis and due to the deformity to the rib cage vertical expandable prosthetic titanium rib (veptr) was chosen as the implant for deformity correction.The initial operation was done sometime in 2012.As the patient grew it was recommended that distraction of the implants occur to accommodate the growth; it was also reported that the patient suffered from severe pain and screw loosening requiring the revisions.Operations to distract the implants were done in 2014 and (b)(6) 2015.During the operations the surgeon requested new longer implants to accommodate the growth for the next distraction.This report is for an unknown veptr implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: patient age, gender, weight is unknown.This report is for an unknown veptr implant/unknown lot.Implant date was in 2012 or 2013; day and month are unknown.Revision procedures occurred in 2014 and (b)(6) 2015 on unknown dates; device were explanted and replaced with longer devices.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.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.

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.It was confirmed there is no allegation/complaint against this device.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: 4912059
• MDR Text Key: 19316227
• Report Number: 2520274-2015-14904
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• 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?: No
• Date Manufacturer Received: 07/23/2015
• 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