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

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown mono/ polyaxial screws/ unknown lot.Part and lot number 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.(b)(4).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: seifen, t.Et al (2015), the value of 18f-fluoride pet/ ct in the assessment of screw loosening in patients after intervertebral fusion stabilization, european journal of nuclear medicine and molecular imaging, vol.42 (2), pages 272-277, (austria).This study aims to evaluate 18ffluoride pet/ ct in the diagnosis of screw loosening in patients with persistent or recurrent back pain after spondylodesis.A total of 59 consecutive patients (39 women, 20 men; mean age 59.5±13.6 years) with persistent or recurrent episodes of pain in the region of previous intervertebral fusion stabilization and therefore suspicion of implant instability due to screw loosening were included in the study.Devices based on a titanium rod screw system were used in all patients.Moss-miami screw was used in 6 patients.The final diagnosis was based on intraoperative exploration and a follow-up of 21 ¿ 36 months (mean 27.7 months) after 18f-fluoride pet/ ct.The following complications were reported: a case of a (b)(6) year-old man with a typical pattern of screw loosening at l4: increased uptake around the screw is shown on the 18f-fluoride pet/ ct image.Of the 59 patients investigated, 20 (18 of 27 patients in the intraoperative exploration group, 2 of 32 during follow-up) were found to be positive for implant failure due to screw loosening.8 patients with screw loosening had radiolucent zone surrounding the screw shaft.1 of these was seen in the focal uptake at the screw entry point, and 7 patients seen in the focal uptake at the screw entry point and surrounding shaft.1 patient with screw loosening had screw displacement seen in the focal uptake at the screw entry point and surrounding shaft.3 patients with screw loosening had screw breakage.2 of these were seen in the focal uptake at the screw entry point and surrounding shaft, while 1 patient had no uptake.Of the 59 patients investigated, 20 (18 of 27 patients in the intraoperative exploration group, 2 of 32 during follow-up) were found to be positive for implant failure due to screw loosening.58 of 156 screws were intraoperatively proven to be positive for loosening.(6 patients were treated with moss miami screws) screw breakage was confirmed in the three of the 156 screws.Revision surgery was recommended in 30 patients but only performed in 27 patients.This report is for an unknown moss miami screw.(b)(4).

• 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 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9531652
• MDR Text Key: 189191666
• Report Number: 1526439-2019-52825
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• 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