MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: ARCH LAMINOPLASTY PLATE; PLATE, FIXATION, BONE

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

Patient Problem Fatigue (1849)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - plates: arch laminoplasty plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

This report is being filed after the review of the following journal article: barkley as, et al.(2021), the rare occurrence of reoperation after cervical laminoplasty a 14-year retrospective review of reoperative rates at a single institution, clin spine surg, volume 34, number 6, pages e342¿e348 (usa).The goal of this 14-year single-institution retrospective study was to determine reoperation rates in general, and rates for correction of recurrent or adjacent-level stenosis specifically, after first-time single open-door cervical laminoplasty for cervical spondylotic myelopathy.Between january 2005 and may 2018, a total of 102 patients who underwent first-time laminoplasty for cervical spondylotic myelopathy were included in the study.The mean age of patients was 56.7 years (±12.96), and the majority of the patient population were men (74.5 percent, n=76).The majority of cases used the unknown synthes arch laminoplasty system which was implanted to 93 patients with 6-mm spacers in 61 cases and 8-mm spacers in 71 cases.The average follow-up time was 6.7 months, ranging from 3 months to 10 years.Complications were reported as follows: 2 patients required reoperation for infection and wound dehiscence.Case 1, a (b)(6) year-old woman with proteus syndrome returned 23 months postoperatively with complaints of recurrent upper extremity paresthesia, diminished dexterity, and worsening ataxia.The patient was severely myelopathic and repeat magnetic resonance imaging demonstrated c4¿c5 level stenosis.6 months later, the patient underwent a revision c3¿c5 laminoplasty with improvement in her symptoms at 1-year follow-up.Case 2, a (b)(6) year-old man presented at 1-year postoperatively with worsening hand intrinsic weakness and an magnetic resonance imaging demonstrated worsened c7¿t1 stenosis.He underwent a c2¿t2 posterior spinal instrumentation and fusion1 month after presenting for these symptoms.At 2-year follow-up, the patient reported improvement in symptoms with some persistent weakness, although improved compared with his preoperative symptoms.This report is for the unknown synthes arch laminoplasty system.This report is for (1) unk - plates: arch laminoplast.This is report 2 of 6 for complaint (b)(4).

• Brand Name: UNK - PLATES: ARCH LAMINOPLASTY PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12445759
• MDR Text Key: 270506393
• Report Number: 2939274-2021-05239
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention