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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article, ¿can veptr control progression of early-onset kyphoscoliosis?¿ patil, v.Md, reinker, k.Md, simmons, j.W.Do, phd, and stinson, z.Md (2011).Clinical orthopaedics and related research, 469:1342-1348.This was a cohort study of veptr patients with severe kyphoscoliosis.Kyphoscoliosis is considered a relative contraindication to treatment with the vertical expandable prosthetic titanium rib (veptr; synthes inc, (b)(4)).Nevertheless, patients do present with early-onset kyphoscoliosis and thoracic insufficiency syndrome, and no suitable alternative treatments are currently available.However, it is unclear whether veptr is reasonable for treating patients with kyphoscoliosis.The authors determined whether veptr controls progression in patients with kyphoscoliosis and, if so, what methods might be used to improve control of deformity progression in these patients.The authors retrospectively reviewed 14 patients who had veptr treatment of early-onset kyphoscoliosis.The cohort included 10 males and four females.The mean age at initial veptr surgery was 3.9 years (range, 1.4¿23.3 years).Six patients had initial proximal anchor placement below the third rib with subsequent increase of kyphosis.While some improvement in the kyphosis was seen after more proximal cradle placement, the increase in kyphosis prompting the change to a higher level did not entirely resolve with the resetting of cradles at the second rib.In seven patients, an inadequate distal lever arm was noted, with distal anchor placements above l3.Improvement of the kyphosis occurred after extension of one or more implants distally to the pelvis or, in one case, to l5.The proximal cradle had to be reseated more than once in seven of our patients.One patient had removal of his hybrid implant after eroding through the rib four times within two years.Two others had to have removal of implants due to infection.Kyphosis progressed in all of these patients.The authors concluded that the progression of kyphosis can be minimized during veptr treatment by early extension of the construct to the second ribs bilaterally, distal extension of hybrid constructs to the pelvis, use of bilateral hybrid veptr implants, and use of redesigned veptr constructs that enhance fixation at the upper end.While our early results suggest these devices control progression of kyphosis, longer followup with more patients will be required to confirm the concept in these patients.There is not sufficient information to file multiple reports.This report is for an unknown veptr construct and refers to the migration of the device.

Manufacturer Narrative

Device used for treatment, not diagnosis.Can veptr control progression of early-onset kyphoscoliosis?¿ patil, v.Md, reinker, k.Md, simmons, j.W.Do, phd, and stinson, z.Md (2011).Clinical orthopaedics and related research, 469:1342-1348.This report is for an unknown veptr construct/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.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: 3771405
• MDR Text Key: 4433098
• Report Number: 2520274-2014-10940
• 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: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• 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: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention