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

Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Issue (2379)

Patient Problems Failure of Implant (1924); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: comparison of complications among growing spinal implants sankar, s., et al (2010).Spine 35: 2091-2096.Usa.This was a retrospective study that evaluated 36 children with early onset spinal deformity who were treated with various types of growing implants by a single surgeon.The patients had undergone growing spine surgery before (b)(6) 2006.The purpose of this study was to evaluate and compare the complication rates in growing spine surgery using various types of growing spine implants and to determine what factors, if any, may be associated with an increased risk for complications.Complications were defined as any neurologic injuries, and any unplanned surgeries for implant failure or infection.Patients were separated into 3 groups: (a) standard dual growing rods, (b) hybrid growing rods with rib anchors proximally and spine anchors distally, and (c) vertical expandable prosthetic titanium rib (veptr: synthes spine co., west chester, pa).Statistical analyses were performed to compare the complication rate among the 3 groups and to evaluate the effect of cobb angle, kyphosis, age, and body mass index on the complication rate.Mean age at initial implantation was 4.8 years; (range, 1.4 ¿9.5 years) and mean follow-up was 4.3 years (range, 2.0 ¿9.8 years); on average, 4 lengthenings were performed on each patient during the study period.Of 36 patients, 26 (72%) had at least 1 major complication.There were 72 unplanned surgeries in these 26 patients including 18 revisions for rod breakage, 31 revisions for loose implants or anchors, and 2 removals of instrumentation because of implant prominence.Eighteen irrigations and debridements were performed on 10 patients who developed deep wound infections.Three patients had neuro-monitoring changes during surgery (8%).One child (male) had his veptr removed immediately after placement because the child awoke with a brachial plexus palsy that resolved within 10 weeks.Another child regained upper extremity signals intraoperatively after reducing the amount of distraction during placement of a hybrid rib to spine growing rod.The last child (male) lost lower extremity motor signals during veptr revision and had a neurologic deficit during the wake-up test.The implants were partially revised until the neuromonitoring signals improved.However, after surgery, the child still demonstrated lower extremity weakness that resulted in 2 additional procedures (partial revision and complete implant removal).For reasons of spinal stability, he eventually underwent a third procedure for partial re-instrumentation, and recovered full lower extremity motor function over the course of 3 months.Given the 36 children in our series, the overall complication rate was 2.06 complications per patient (206%).Broken down by construct, group a had 23 major complications in 10 patients, with a complication rate of 2.3 per patient; group b had 6 major complications in 7 patients, with a rate of 0.86 per patient; and group c had 45 major complications in 19 patients, with a complication rate of 2.37 per patient.The authors concluded that in contrast to previous studies, their series demonstrates a much higher complication rate ((b)(6)/patient) for children undergoing growing spine surgery.They found the complication rate in growing spine surgery varies by implant type, with a trend toward the hybrid construct being the lowest.This report refers to the 72 unplanned surgeries in 26 unidentified patients that included: 18 revisions for rod breakage, 31 revisions for loose implants or anchors, and 2 removals of instrumentation because of implant prominence.Likewise, it is for 10 unidentified patients who developed deep wound infections and had 18 irrigations and debridements.This is report 3 of 3 for (b)(4).This report is for: unknown veptr.The 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 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: 4584215
• MDR Text Key: 14877264
• Report Number: 2520274-2015-11528
• 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: 03/10/2015
• 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