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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014 that an anticipated veptr lengthening procedure became a revision because the implant had migrated outside of the ribs.During the revision, the cap holding forceps had lots of torque or force placed on the instrument and the tip broke off.No delay reported and the tips were retrieved.A similar device was used to successfully complete the procedure.The patient was a female approximately (b)(6) years old with severe kyphosis.She had a veptr placed; original surgery date unknown.On (b)(6) 2014, the patient was due to have a lengthening procedure done.Once patient was brought to the operating room it was noted that the veptr had migrated out of the ribs.The rib was cracked (location unknown).The surgeon disassembled the cradle construct and replaced/explanted some of the construct.The ribs were fused to create a channel.During the revision the cap handling forceps broke.The tip was easily retrieved.Operation was only delayed a minute or two.Patient is recovering.The explanted parts were thrown out.The implant construct stayed intact.The cap handling forceps have been returned for investigation.This report is 1 of 2 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown number of devices - veptr/unknown lot/part numbers.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.

Manufacturer Narrative

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

(b)(4).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.

• Brand Name: UNKNOWN - VEPTR
• 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: 4104807
• MDR Text Key: 4717424
• Report Number: 2520274-2014-13734
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• 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: 03/28/2015
• 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