MAUDE Adverse Event Report: SYNTHES(USA); PROTHESIS, RIB REPLACMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994); Tissue Damage (2104)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: smith, j., et al (2009): the role of bracing, casting, and vertical expandable prosthetic titanium rib for the treatment of infantile idiopathic scoliosis: a single-institution experience with 31 consecutive patients.J neurosurg spine11: 3-8.Usa article.This was a retrospective study that was conducted to evaluate the method of treatment used to manage 31 patients with infantile idiopathic scoliosis at a single institution.The patients had been treated between 2000 and 2008 with 1 of 3 modalities: bracing, body casting, or vertical expandable prosthetic titanium rib (veptr).Patients were excluded from the study is they had significant medical comorbidities, congenital anomalies, or syndromes that may have contributed to the spinal deformity.The study group consisted of 22 girls and 9 boys.The average age at diagnosis was 13.6 months (range 1¿36 months).The average age when casting, bracing, or veptr (synthes) treatment was initiated was 25.5 months (range 3¿84 months).The average duration of follow-up was 32 months (range 6¿103 months).Patients were generally evaluated every 4¿6 months with standard posterior-anterior and lateral full-spine radiographs.Of the 31 patients, 17 were treated with a brace, 9 of whom had curve progression and went on to other forms of treatment.Of the 8 who did respond, there was an overall improvement of 51.2%.The 10 patients who received body casts, who had a mean preoperative cobb angle of 50.4°, demonstrated an average correction of 59.0%, with only a few skin irritations reported.The 10 patients treated with veptr devices demonstrated a mean preoperative cobb angle of 90.0°, and an average correction of 33.8% was attained.Overall, 3 (33%) of the 9 veptr-treated patients incurred a complication.Two patients had erosion of the proximal rib attachment that required replacement, which was performed during routine expansion.The third patient experienced 2 weeks of postoperative leg pain that resolved without intervention.Despite these complications, all veptr-treated patients still retain their devices.The authors concluded that bracing alone proved effective in only 47% of patients.Casting provided excellent maintenance of curve correction, with no patients progressing to require surgical intervention.Finally, veptr was shown to be an effective means of management for larger, more rigid curves, with a comparatively smaller complication rate when compared with other surgical modalities.Larger, long-term, prospective studies are certainly warranted to provide more definitive treatment recommendations for the future.This is report 1 of 1 for (b)(4).This report is for an unknown veptr/unknown quantity/unknown lot.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).This report is for an unknown veptr/unknown quantity/unknown lot.(b)(6).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROTHESIS, RIB REPLACMENT
• 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: 4579808
• MDR Text Key: 5342769
• Report Number: 2520274-2015-11523
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/15/2015
• Initial Date FDA Received: 03/09/2015
• 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