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

Device Problems Break (1069); Entrapment of Device (1212); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws: uss/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: john s.Thalgott et.Al (2001), instrumented posterolateral lumbar fusion using coralline hydroxyapatite with or without demineralized bone matrix, as an adjunct to the autologous bone, the spine journal, vol.1(2), pages 131-137 (usa) https://doi.Org/10.1016/s1529-9430(01)00011-0.The aim of this article is to determine the efficacy of coralline hydroxyapatite with or without demineralized bone matrix as a bone graft extender in a human clinical model with long-term follow-up.A total of 40 patients (14 male and 26 female) with a mean age of 62 years (range, 25-77years) were included in the study.All patients underwent transpedicular fixation with autogenous posterolateral lumbar fusion.All patients were implanted with synthes uss.The mean duration of follow-up was 53 months with a range of 28-70 months.The following complications were reported as follows: 2 patients had 2 doral tears.1 patient had one-foot drop which did not resolve.5 patients had continued pain and suspected pseudarthrosis was 4 patients found to be solidly fused by direct exploration of the fusion mass.6 patients experience excellent pain (table 2).12 patients experience good pain (table 2).10 patients experience fair pain (table 2).12 patients experience poor pain.(table 2).An (b)(6) year-old female patient had a hardware removal due to residual leg pain and the desire to remove the hardware.A (b)(6) year-old patient has the screw at l2 appear to be violating the disc space.1 patient had a malpositioned screw.1 patient had retained broken screw.1 patient had partial removal.(b)(6) year old arthritic male patient (74 years at the time of follow-up) presenting with failed laminectomy syndrome and spinal stenosis.A (b)(6) year-old man (66 years old at the time of follow-up) presenting with a prior pseudarthrosis and failed laminectomy syndrome at l4¿5 and l5¿s1.The patient was instrumented with subsequent posterolateral fusion.No grafton dbm was used.The radiograph clearly shows partial resorption on the right.This patient was judged to be solidly fused at both levels despite the partial resorption.This report is for a unknown- mono/polyaxial screws: uss.This is report 4 of 6 for (b)(4).

• 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: 8570805
• MDR Text Key: 143811252
• Report Number: 2939274-2019-57764
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention