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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob & weight not provided for reporting.This report is for unknown veptr ii system/unknown lot number.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history record review and 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.

Event Description

: device report from synthes on an event in (b)(6) as follows: it was reported that the veptr ii (vertical expandable prosthetic titanium rib ii) system was initially implanted to the left-5th rib ¿ 12th rib and the left-4th rib ¿ 4th lumbar for the patient suffering from progressive scoliosis associated with severe thoracic deformation and cleidocranial dysostosis on (b)(6) 2012.The involved product was used for the patient on (b)(6) 2015.On (b)(6) 2016 (the day before the scheduled extension surgery), it was found the cranial cradle in question was dislocated.On the scheduled extension surgery of (b)(6) 2016, the cranial cradle (left hybrid type) was changed and the length was extended 1 cm.The type of the cradle was not extended.The patient was recovered- this confirmation was on dated of july 27, 2016.The patient was hospitalized long time due to amputation stump plasty of left-lower leg.There is no information available about surgical outcome.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Date of event is unknown.Reporter phone number: (b)(6).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

Second surgery was successfully completed.There was no issue during initial surgery.The mentioned cradle in description is the one used on head side not hip side.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6223144
• MDR Text Key: 63877657
• Report Number: 2520274-2017-10027
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• 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: 01/17/2017
• 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: 9 YR