MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

Event Description

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: kamenova m., et al (2022) posterior stabilization with polyetheretherketone (peek) rods and transforaminal lumbar interbody fusion (tlif) with titanium rods for single-level lumbar spine degenerative disease in patients above 70 years of age, archives of orthopaedic and trauma surgery xxxx, pages 1-13 (switzerland).This study aims to compare retrospectively reoperation rates and clinical outcome in patients above the age of 70 years with one-level lumbar spine degenerative disease treated by tlif with titanium rods or posterior stabilization with peek rods.From march 2014 to july 2020, patients, older than 70 years, undergoing posterior stabilization with peek rods or tlif with titanium rods for a single-level lumbar degenerative disease were reviewed.76 patients (69.7% females) were included in the ¿peek group¿ and 67 patients (52.2% females) were included in the ¿tlif group¿ (of these, 3 patients received a minimally invasive (mis) tlif).Patients in the tlif group were using pedicle screws (expedium®, depuy synthes companies, j&j medical devices) were inserted into the pedicles at the appropriate levels.Autologous bone mixed with grafton¿ dbm was packed into the disc space.The screws were then connected by titanium rods.A mix of autologous bone and grafton¿ dbm was placed over the facet joints and transverse processes (posterolateral fusion) in 36 patients, while in 31 patients only autologous bone was used for the posterolateral fusion.Mis tlif patients (n = 3) were operated through an incision made at the level of the facet joint to be resected in the prone position.The screws were then connected by titanium rods.Local/ autologous bone and grafton¿ dbm were placed over the facet joints and transverse processes (posterolateral fusion).Patients in the peek rod group were also operated through a midline incision in the prone position.Pedicle screws (expedium®, depuy synthes companies, j&j medical devices) were inserted into the pedicles at the appropriate levels.The screws were then connected by peek rods.Autologous bone graft and grafton¿ dbm were placed over the facet joints and transverse processes (posterolateral fusion) in 12 patients , while in 54 only autologous bone graft was used.Mean first clinical and radiological follow-up time was 80 ± 33.1 days in the tlif group and 73.7 ± 27.8 days in the peek rod group.Last clinical and radiological follow-up time on average was 282.6 ± 150.4 days in the tlif group and 300 ± 134.1 days in the peek rod group.Tlif group: 1 pedicle screw loosening managed with reoperation at first follow up.1 pedicle screw loosening managed with revision , in patients older than 80 years , at first follow up.Peek rod group: 2 pedicle screw loosening ,1 reoperation at first follow up.1 pedicle screw loosening managed with revision , in patients older than 80 years , at first follow up.1 pedicle screw loosening.1 revision surgery at last follow-up.1 pedicle screw loosening managed with revision , in patients older than 80 years ,at last follow up.Tlif group: at first follow up: 4 insufficiency fracture, 1 in patients older than 80 years, and were managed with reoperation.4 reoperation , 1 in patients older than 80 years, due to wound healing disorders.1 reoperation due to asd in patients older than 80 years.At last follow-up: 6 asd and 4 had revision.1 delayed union managed with revision.After complete regular follow-up, 3 patients presented with new symptoms: 1 claudication, 2 pseudoradicular pain , 1 in the patient older than 80 years.3 surgical complications during hospitalization.1 surgical complications needing revision surgery.1 epidural hematoma.1 wound healing disorder.Postop.Segmental lordosis.Postop.Overall lordosis.4 worse symptoms at first fu and 3 at last fu.7 same symptoms at first fu and 4 at last fu.Peek rod group: at first follow up: 4 asd, 2 in patients older than 80 years , managed with reoperation due to asd (n = 3).4 insufficiency fracture, 1 in patients older than 80 years, managed with reoperation (n = 2).Reoperation due to wound healing disorders (n = 2).At last follow up: 9 asd, 1 in patients older than 80 years , with revision due to asd (n = 4).1 insufficiency fracture and was managed with revision.After complete regular follow-up, 5 patients presented with new symptoms: 2 claudication and 3 radicular pain, 1 in patients older than 80 years.Of these, only one patient in the peek rod group was treated surgically for symptomatic asd.4 surgical complications during hospitalization.1 surgical complications needing revision surgery.2 epidural hematoma.Postop.Segmental lordosis.Postop.Overall lordosis.5 worse symptoms at first fu and 2 at last fu.9 same symptoms at first fu and 7 at last fu.This report is for unknown synthes pedicle screws (expedium®0).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14685799
• MDR Text Key: 294909287
• Report Number: 1526439-2022-00831
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• 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: 05/17/2022
• 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
• Treatment: CAGE; GRAFTON¿ DBM; PEEK RODS SYSTEM
• Patient Outcome(s): Other