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

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: surgical complications in early onset scoliosis.Phillips, j., et al (2007).Journal 1: 255-276.(usa) between (b)(6) 2002 and (b)(6) 2005 a total of 44 surgical procedures were performed in 20 young scoliosis patients involving the use of unfused instrumentation.Average age was 8 years-1 month, range 2 + 3 to 12 + 7.Total number of procedures was 44, average 2.2.And only one patient has gone on to definitive fusion at this point.This indicates the early stage of development of this program at our center.All patients received either isola growing rod instrumentation or veptr.There was a 100% complication rate in the veptr patients and 64% in the growing rods.20% of total complications occurred in patients who moved to our area from out of state and were established complications, sometimes after multiple surgeries done elsewhere.Our local complication rate was 45% which is nearly identical to published literature (akbarnia et al.2005).There was an alarmingly high rate of deep infection which occurred early in the veptr group and late after many lengthenings in the growing rod group.Of nine infections, implants were salvaged in only two cases.The others all need to be removed and definitive treatment of the scoliosis is still pending.There was one perioperative death in the group.There was one transient intraoperative neurological deficit with no permanent loss postoperatively.A large variety of very rare syndromes comprised much of this group.As in other reports, implant cut out and breakage constituted the majority of non infectious complications.These patients represent a high risk group but seem to have a complication rate in excess of other high risk patients.For example, our group reported an 8% infection rate in definitive fusion for neuromuscular scoliosis recently (phillips et al.2005).Our infection rate for this early onset group was five times greater.It is assumed that the multiple surgeries for rod lengthening lie at the heart of this high complication rate and strategies to avoid repeated open procedures may reduce the rate of infection at least.The fact that 20% of complications were inherited from other centers in the usa underlies the need for a central data bank of this small group of patients to truly delineate outcomes in early onset scoliosis surgery.This is report 1 of 1 for com-(b)(4).This report is for unidentified patieint's for an unknown veptr a copy of the literature article is being submitted with this article.

Manufacturer Narrative

Device used for treatment, not diagnosis.Surgical complications in early onset scoliosis.Phillips, j., et al (2007).Journal 1: 255-276.(usa) this report is for an unknown veptr/unknown quantity/unknown lot.(b)(6).(b)(4).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 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: 4592166
• MDR Text Key: 19764280
• Report Number: 2520274-2015-11677
• 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: Foreign,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: 03/11/2015
• 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