MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: ZERO-P; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Failure of Implant (1924); Nerve Damage (1979); Osteolysis (2377); Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 06/01/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: fayed i., et al (2021) comparison of clinical and radiographic outcomes after standalone versus cage and plate constructs for anterior cervical discectomy and fusion, international journal of spine surgery, vol.15, no.3, pp.403¿412 (usa).This retrospective study aims to add a larger single-institution case series to the literature that directly compares the outcomes of plated versus standalone acdf constructs as an index procedure with respect to revision rate, perioperative metrics, postoperative dysphagia, and hoarseness.In (b)(6) 2011, all index acdf procedures performed by 5 spine fellowship-trained attending neurosurgeons since the implementation of our institution¿s electronic medical record was conducted.All patients were 18 years of age or older and had at least 6 months of follow up.A total of 321 patients underwent acdf and met inclusion and exclusion criteria, with a mean follow-up duration of 18.2 6 0.7 months.Patients were divided into 2 groups: standalone versus plated constructs.Forty-six patients received standalone constructs, while 275 received plated constructs.The mean age was 58.1 6 1.9 years in the standalone group, 57.7 6 0.7 years in the plated group, and 57.8 6 0.6 years overall.Polyetheretherketone (peek) cages were used in all cage-and-plate constructs, with a variety of different plating systems.The zero-p (depuy synthes, (b)(4)), coalition mi (globus), or scarlet (spineart) standalone devices were used for standalone cases.Reported complications: 4 revisions due to asd, hardware failure, or persistent-recurrent compression of neural elements.All 4 revisions in the standalone group was on zero-p devices.Cervical lordosis.33 % change in interspinous distance.2 mm.This report is for unk - screws: zero-p.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown device/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.

• Brand Name: UNK - SCREWS: ZERO-P
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15122955
• MDR Text Key: 296792113
• Report Number: 2939274-2022-02992
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 06/30/2022
• 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