MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Osteolysis (2377); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/ polyaxial screws/ unknown lot.Part and lot numbers are unknown; udi 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.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

This report is being filed after the review of the following journal article: hayati a, osman y, muren m (2017), does the addition of a dynamic pedicle screw to a fusion segment prevent adjacent segment pathology in the lumbar spine? asian spine journal, volume 11 (5), pages 715-721, (turkey).The purpose of this study was to investigate whether the combined use of dynamic pedicle screws and polyaxial pedicle screws was effective on adjacent segment pathology (asp).Between 2007 and 2014, 101 patients who underwent lumbar segmental spinal fusion for degenerative spine diseases were included in the study.The patients comprised 53 females and 48 males, with a mean age of 53 years (range, 38¿78 years).The patients were analyzed in two groups poliaxial pedicle screw (pps) and poliaxial pedicle screw+dynamic pedicle screw (pps+dps) according to the technique used.In the pps group, 59 patients underwent posterolateral fusion after laminectomy and decompression with demineralized bone matrix (dbm) grafts and unknown depuy spine polyaxial pedicle screw rods plus unknown depuy spine interbody polyetheretherketone (peek) cages.A total of 127 segments were fused.In the pps+dps group, 42 patients also underwent lumbar spinal fusion; in addition, a competitor¿s dynamic pedicle screws with hinged screw heads were added to the adjacent segments at the end of the fused segment.In this group, 84 segments were fused and 53 segments were added to these segments as dynamic segments.The patients were followed up for an average of 79 months (range, 55¿90 months.Pps group: 8 patients had adjacent segment disease in caudal segments.6 patients had adjacent segment disease in cranial segments.1 patient had dural tear.2 patients had radiculopathy.1 patient had infection.3 patients had pseudoarthrosis.1 underwent surgical revision while the others were followed up without complications.2 patients had screw loosening.Pp+dps group: 5 patients had adjacent segment disease in caudal segments.3 patients had adjacent segment disease in cranial segments.1 patient had dural tear.1 patient had radiculopathy.1 patient had pseudoarthrosis.1 patient had screw loosening.This report is for the unknown depuy spine polyaxial pedicle screw rods and unknown depuy spine interbody polyetheretherketone (peek) cages.

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: kara ditty-bovard ; chemin blanc 38; le locle 02767 ; SZ 02767 ; 6103142063
• MDR Report Key: 11817144
• MDR Text Key: 261953639
• Report Number: 1526439-2021-00944
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/13/2021
• 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