MAUDE Adverse Event Report: SYNTHES USA; TEMPLATE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Date of event: schimmel, j; et al (2016) peek cages in lumbar fusion mid-term clinical outcome and radiologic fusion.Cin spine surg vol 29: 5, june.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after subsequent review of the following literature article: schimmel, j; et al (2016) peek cages in lumbar fusion mid-term clinical outcome and radiologic fusion.Cin spine surg vol 29: 5, june.This study is to evaluate mid-term clinical outcome and radiologic fusion in patients treated with a polyetheretherketone (peek) cage.From december 2004 until august 2007.A total of 95 patients (46 men and 54 women) were operated either at l3¿l4, l4¿l5, and/or l5¿s1 with the synfix-lr cage.Their mean age at surgery was 43.4 (±9.3) years.The number of reoperations was counted.Short-term complications after the initial surgery included: 1 case of retrograde ejaculation, 1 case suffering from an abdominal hematoma and urine retention, and 1 patient suffered from an infection at the crista.All short-term complications were successfully treated conservatively and/or with the appropriate medication.In total, 26 patients were reoperated after a median period of 17.6 months (range, 6.7¿46.9) of the initial surgery, of whom 23 patients (24.2%) were reoperated because of a symptomatic pseudarthrosis.In 1 double-level patient, both levels were pseudarthotic resulting in 24 of 116 failed cages.In all the cases, it was possible to leave the cages in situ.Three patients were reoperated not because of symptomatic pseudarthrosis.First, a single-level patient underwent additional surgery after 14 months, in whom the iliac crest was operatively flattened because of a sharp bone surface after harvesting for the bone graft.The second patient (double-level) underwent an additional surgery because of a neuroma and exostosis of the iliac crest 37 months after the initial surgery.The last patient who initially received a synfix- lr at level l4¿l5 underwent 4 additional surgeries.One year after the initial surgery, an interspinous process spacer (diam implant) was placed at level l3¿l4; 15 months later, a repeat fusion was performed with translaminar screws at level l3¿l4¿l5, a diam implant at level l2¿l3, and an allograft.Thereafter, a deep wound infection occurred, which was successfully treated with 2 additional surgeries, including debridement of the infected tissue, pulsed lavage irrigation, and gentamycin beads.Clinicians should be alert on pseudarthrosis when patients treated with the synfix-lr cage presented with persisted or aggravated complaints.This is 9 of 9 for (b)(4).This report is for an unknown synfix ¿lr and refers to the serious injury of case 82 who experienced symptomatic pseudarthrosis, re-exploration after suspicious infection and wound dehiscence.

• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6085527
• MDR Text Key: 59452359
• Report Number: 2520274-2016-15265
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• 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