MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS; SCREW, FIXATION, BONE

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown - screw/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.Investigation summary 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, 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: haufe, s.M.W., mork, a.R., and kunis, c.C.(2008), surgical considerations of entire lumbar spine hardware removal via a minimally invasive approach, journal of surgical orthopaedic advances, vol.17 (2), pages 82¿84 (usa).The aim of this retrospective study is to presents findings on utilizing an endoscopic approach to the removal of spinal hardware, the complications associated with this technique, and other related technical issues that would be pertinent to the surgeon.Between 2001 to 2003, a total of 13 patients (7 male and 6 female) with the median age of 52 (range 37 to 70) years underwent hardware removal.Devices in the study included seven different hardware systems from synthes and some competitor's device.The follow-up period is 6-months interval.The following complications were reported as follows: 13 patients underwent hardware removal via endoscopic approach because of residual neural compression due to either the hardware or foraminal stenosis, but some difficulties were noted.One difficulty was that the screws were quite large, which required us to enlarge the working tube diameter to 18 mm for some of the hardware systems.Stripped screw heads from the hardware insertion made their removal difficult.Unfamiliarity with the hardware systems because these hardware systems were implanted by other surgeons, having to cut the crossbars, and stripped screws from the original hardware insertion led to most of the extra time required for the hardware removal.1 patient developed signs of instability after the removal of the hardware and this was confirmed with sequential spinal x-ray series and underwent a repeat fusion operation at a later date.10 of the 13 patients went on to undergo decompressive surgery to eliminate the radicular symptoms.1 of the 12 patients, who did not develop any significant improvement with the hardware removal, opted not to undergo the decompressive surgery.Of the 10 patients who underwent endoscopic decompressive surgery following the hardware removal, 2 patients developed 1% to 24% improvement, 2 developed 25% to 49% improvement, and 1 developed 50% to 74% improvement.Of the other 5 patients, 4 claimed no change in their pain levels following the decompressive surgery and 1 claimed a 1% to 24% increase in their pain post surgery.Cutting of the crossbars amounted to an extra 15 minutes for stainless steel crossbars and up to 1 hour for titanium units.Reasons for the crossbar needing to be cut usually involved issues such as inability to remove stripped screws, bent bars, or bone fusion overgrowth, which caused the bar to be immobile.This impacted product captures the reported: difficulty of removal due to large screws and stripped screw heads.In 1 patient, the screw head had to be ground away via our carbide burr system, which added significantly to the overall time of the surgery.This report is for one (1) unk - screw.This report is for an unknown synthes spine and unknown synthes spine screws.This report is 2 of 5 for (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW, 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9177132
• MDR Text Key: 167789033
• Report Number: 2939274-2019-61417
• Device Sequence Number: 1
• Product Code: HWC
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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
• Date Manufacturer Received: 09/20/2019
• 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