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

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: elgafy h., et al (2021) lumbar spine fusion outcomes using a cellular bone allograft with lineage committed bone-forming cells in 96 patients, bmc musculoskeletal disorders volume 22, pages 1-10 (usa).This retrospective study aims to assess clinical outcomes in patients undergoing instrumented posterior lumbar fusion (iplf) surgeries with and without transforaminal interbody fusion (tlif), and using viable osteogenic cells (v-cba), who had baseline comorbidities and lifestyle risk factors known to negatively affect bone fusion.From january 2016 to november 2018, patients undergoing iplf procedures with or without tlif performed by the first author (he) using v-cba at an academic medical center were identified.A total of 96 patients were assessed (iplf n = 13; iplf+tlif n = 83) with a mean age (sd) of 58.9 (11.4) years (iplf = 64.9 [10.2] years; iplf+ tlif = 57.9 [11.3] years).Among iplf only patients, the majority were male (8 patients).Among iplf only patients, the majority were male (8 patients) all study patients underwent iplf procedures with or without tlif, and with v-cba.The instrumentation used was the universal spine system¿ (depuy synthes, raynham ma) and a structural interbody allograft spacer (vertigraft®; lifenet health®, virginia beach va) was used for the tlif procedures.The reported follow-up times ranged from 6 to 45 months with a median of 16 months.The following complications were reported as follows: 62-year-old female (id no.(b)(6)) considered not fused (lenke c ).Available patient-reported pre- to postoperative, vas remained relatively consistent.44-year-old male (id no.(b)(6)) considered not fused (lenke d).Available patient-reported pre- to postoperative, vas remained relatively consistent.41-year-old female (id no.(b)(6)) considered not fused (lenke d).Available patient-reported pre- to postoperative, vas remained relatively consistent.34-year-old male (id no.(b)(6)) considered not fused (lenke c ).Available patient-reported pre- to postoperative, vas remained relatively consistent.62-year-old male (id no.(b)(6)) considered not fused (lenke d).Available patient-reported pre- to postoperative, vas remained relatively consistent.68-year-old male (id no.(b)(6)) considered not fused (lenke d).Available patient-reported pre- to postoperative, vas remained relatively consistent.85 -year-old male (id no.(b)(6)) considered not fused (lenke d).Available patient-reported pre- to postoperative, vas remained relatively consistent.68-year-old male (id no.(b)(6)) considered not fused (lenke d).Available patient-reported pre- to postoperative, vas remained relatively consistent.This report is for unknown synthes universal spine system¿.This is report 8 of 8 for complaint.

Manufacturer Narrative

Additional narrative: 510k: this report is for an unk - constructs: uss/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 - CONSTRUCTS: USS
• 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 wright lane east; west chester 19380 ; 3035526892
• MDR Report Key: 14982527
• MDR Text Key: 295680251
• Report Number: 2939274-2022-02604
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 06/13/2022
• 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