MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC BKP CEMENT

Model Number MSB_UNK_BKP_CEMENT

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Intervertebral Disc Compression or Protrusion (4524)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Age: mean age of 76 years (range 69-87 years).Sex: 11 male and 43 female patients.Product code: ndn.Common device name: cement, bone, vertebroplast.Country: (b)(6).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: gaston camino willhuber, gonzalo kido, matias pereira duarte, martin estefan, mariana bendersky, julio bassani, matias petracchi, marcelo gruenberg, and carlos sola.Percutaneous cement discoplasty for the treatment of advanced degenerative disc conditions: a case series analysis.Retrospective analysis.Global spine journal 2020, vol.10(6) 729-734.Doi: 10.1177/2192568219873885.Event summary: it was reported from the literature article that fifty-four patients with advanced disc disease with/without degenerative scoliosis treated with pd with at least 1 year follow-up were studied to describe the results after a minimum 1-year follow-up in patients treated with percutaneous discoplasty (pd), a minimally invasive technique to treat low back pain in elderly patients with advanced degenerative disc disease.The procedure consists in improving stability by injecting bone cement in a severely degenerated pneumodisc.A prospective case-series analysis was conducted.Between december 2015 and september 2017 with inclusion criteria of patients older than 65 years, history of mechanical low back pain reluctant to a minimum of 6 months of conservative treatment, tomographic evidence of vacuum phenomenon and subchondral sclerosis at the affected level and variation in intervertebral disc alignment at the levels involved between standing and supine radiographs in both anteroposterior and lateral views (accordion phenomenon).Based on the diagnosis, 2 groups were created: the scoliotic group with 37 cases of degenerative scoliosis, and a nonscoliotic group with 15 cases of advanced degenerative disc disease without scoliosis plus 2 cases of degenerative spondylolisthesis. fifty-four patients fulfilled the inclusion criteria: 11 males and 43 females with a mean age of 76 years (range 69-87 years).A total of 131 levels were treated, with an average of 2.5 levels per patient (range of 1-5 levels).Pd was performed in 5 patients at the t12-l1 level; 16 patients at l1-l2; 29 patients at l2-l3; 26 patients at l3-l4; 32 patients at l4-l5, and 23 patients at l5-s1. the average operating room time was 38 minutes (range 18-52 minutes).The mean follow-up was 16.8 months + 3.3 (range 12-21 months). polymethylmethacrylate (pmma) (kyphon hv-r bone cement) was slowly injected through the cannula with special attention to detect any sign of cement leakage into the canal or the foraminal space.Reported events: there were no cases of clinical complications such as pneumonia, urinary infection, venous thrombosis, and so on.1. four cases required foraminal decompression due to radicular symptoms within 90 days (7.4%), within these cases; 2 had cement leakage to the foramen, 1 case experienced a disc extrusion, and 1 case had lbp relief but persistent sciatic pain that required foraminal decompression.2.One patient presented a deep infection.3.One patient presented a vertebral fracture adjacent to the discoplasty that required a vertebroplasty.

• Brand Name: BKP CEMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11869137
• MDR Text Key: 252923344
• Report Number: 1030489-2021-00682
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BKP_CEMENT
• Device Catalogue Number: MSB_UNK_BKP_CEMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR