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

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an unknown spine plates/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.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: jack, m.M.Et al.(2021), four-level anterior cervical discectomy and fusions results following multilevel cervical fusion with a minimum 1-year follow-up, clinical spine surgery, vol.34, number 4, pages e243-e247 (usa).This is a retrospective review of prospectively collected data regarding the clinical outcomes, complications, and fusion rates of patients who underwent a 4-level (c3¿c7) anterior cervical discectomy and fusion (acdf).Between 1994 and 2011, 48 patients underwent a single anterior procedure, only 5 patients underwent concurrent anterior and posterior fusion, and 7 patients required a second posterior surgery due to new-onset or residual symptoms or hardware complications after undergoing acdf.Implants used were synthes plates and screws.The follow-up period was at least 12 months.The following complications were reported as follows: 7 patients required a posterior surgery after the anterior operation due to new-onset or residual symptoms or hardware complications.Early complications 11 patients had mild dysphagia.8 patients reported resolution of dysphagia symptoms by 8-week follow-up.1 patient required placement of a percutaneous endoscopic gastrostomy tube before discharge due to severe dysphagia symptoms, however, symptoms significantly improved within 3 months with only mild dysphagia symptoms persisted.Another patient reported difficulty swallowing for up to a year following anterior fusion but completely resolved within 18 months.1 patient developed a hematoma with neck edema and subsequent respiratory arrest following surgery that required immediate evacuation and tracheostomy placement.1 patient developed brown-sequard syndrome secondary to spinal cord edema that resulted in newonset bowel and bladder incontinence requiring straight catheterization.2 patients had weakness.1 patient had raspatory arrest.1 patient had dee[ venous thrombosis.1 patient had bowel/bladder incontinence.Late complications: 11 patients had hardware failure.9 cases of screw backout.1 case of plate fracture, and a single case of anterior plate migration.This patient required reoperation when the plate disengaged and migrated anteriorly and had no further complications.All other patients elected to not undergo correction without any complications.8 patients reported dysphagia after hospital discharge at some point during their follow-up.Six of these patients reported resolution of the dysphagia over their follow-up course.1 patient had a subtotal thyroidectomy performed by general surgery at the time of anterior fusion and subsequently developed persistent dysphagia and vocal cord paralysis.The patient improved with ent intervention and therapy.1 patient who reported dysphagia symptoms during follow-up was later found to have laryngeal cancer.7 patients had residual neck pain.6 patients had residual paresthesia.3 patients had new-onset weakness.6 patients had residual extremity pain.1 patient had cellulitis.1 patient had c5 radiculopathy.This report is for an unknown synthes plates.This report captures the reported event of 1 case of plate fracture, and a single case of anterior plate migration.This patient required reoperation when the plate disengaged and migrated anteriorly and had no further complications.All other patients elected to not undergo correction without any complications.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - PLATES: SPINE
• 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: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14058794
• MDR Text Key: 290462193
• Report Number: 2939274-2022-01246
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: 03/11/2022
• Initial Date FDA Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention