MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Necrosis (1971); No Code Available (3191)

Event Date 01/04/2004

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes 5-mm titanium rod of the small-stature universal spine system/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: odent t, arlet v, ouellet j, bitan f (2004).Kyphectomy in myelomeningocele with a modified dunn-mccarthy technique followed by an anterior inlayed strut graft.European spine journal.Volume 13.Page 206-212.(canada).This retrospective study reports the results of a postero-anterior sequence designed by the senior author.9 myelomeningocele patients, with rigid lumbar or thoracolumbar congenital kyphosis treated with a posterior kyphectomy instrumented with a modified dunn-mccarthy technique followed by an anterior sequence with inlay anterior strut grafting, were included in the study.There were 7 boys and 2 girls with a mean age of 8.8 years (range, 5-13 years).8 patients were implanted with an unknown synthes 5-mm titanium rod of the small-stature universal spine system while 1 patient was implanted with a pediatric isola rods system from depuy spine during the first stage of the surgical procedure.The degree of correction was analyzed postoperatively.A second stage was done several weeks later consisting of a thoraco-abdominal approach to the spine with an inlay strut graft classically from t10¿s1.Measurements included the pre- and post-op angular kyphotic deformity and at the last follow-up.The mean follow-up was 34 months (range 1¿5 years).The article did not specify which of the 9 patients were implanted with the synthes device.Thus, complications will be reported as follows: a (b)(6) year-old female child had posterior bursitis at 1-year after surgery and required debridement and partial hardware removal.A (b)(6) year-old male child had a cerebrospinal fluid leak and had wound necrosis that required a secondary excision, a dural tear suture and a closure by a latissimus dorsi flap.A deep venous thrombosis was observed.A (b)(6) year-old male child had a cerebrospinal fluid leak that resolved without treatment.A (b)(6) year-old male child had a cardiac arrest fortunately reversible during the surgery.The cardiac arrest occurred during the kyphectomy and the patient required to be closed in an emergency without the rods.The correction has been done 2 weeks later reinserting the rods without any specific complications.An (b)(6) year-old male child had syringo-pleural shunt injury.A (b)(6) year-old male child had a cerebrospinal fluid leak but did not require reoperation.This report is for a (b)(6) year-old male child who had a cerebrospinal fluid leak and had wound necrosis that required a secondary excision.This report is for an unknown synthes 5-mm titanium rod of the small-stature universal spine system.This is report 2 of 4 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8501805
• MDR Text Key: 141573108
• Report Number: 2939274-2019-57426
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2019
• 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
• Patient Age: 10 YR