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

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient id and weight are unknown.This report is for an unknown veptrii (size 9) implant/unknown lot.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the replacement surgery was performed due to implant dislocation for the patient treated for congenital scoliosis.On (b)(6) 2015: vertical expandable prosthetic titanium rib ii (veptrii) (size 9) ranging from the right eighth rib to l2 was replaced.On (b)(6) 2015: the patient visited the hospital because a hump was noted on the right side of his back; the hump was noticed around (b)(6) 2015.X-ray images showed that no implants had come off, so the surgeon took a wait-and-see approach.On (b)(6) 2015: the hump was noted at the regular follow-up visit.The surgeon planned to replace the implants though they seemed to be in place.On (b)(6) 2015: the replacement surgery was performed.Since the right eighth rib with the proximal cradle had been dislocated backward, the surgeon changed the position of the cradle from the right eighth to the right ninth rib, and placed veptrii through l2.This report is for an unknown veptrii (size 9) implant.This is report 1 of 1 for (b)(4).

• 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: 5021228
• MDR Text Key: 23701216
• Report Number: 2520274-2015-15377
• 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: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• 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: 08/06/2015
• 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: 8 YR