MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK MONO/POLYAXIAL SCREWS; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for a total of 56 patients who underwent alif where syncage evolution was used for anterior support at aalborg university hospital from 2014 to 2020.In all cases the synframe® retractor system was used.All patients underwent posterior fixation with different pedicle screw systems during the second stage of surgery.In 30 patients a percutaneous pedicle screw system was used ¿ viper (depuy synthes) in 24 patients and competitor in 6.In the last 26 patients expedium ¿ depuy synthes in 1 patient and the rest of the patients with competitor device.The following complications were reported as follows: 1 patient had non-union at two levels.This patient had continued to use non-steroidal anti-inflammatory drugs (nsaids) for the duration of the first year are surgery ¿ contradictory to the given advice.She was reoperated with a posterior approach and insertion of tlif cages and bone graft after removal of as much as possible of the two syncage evolution cages via bilateral tlif approaches.These were the only complications directly associated with syncage evolution.The non-union rate was 1.8 percent of patients (1/56) or 2.5 percent of cages (2/80).7 patients had perioperative complications, 3 of which required reoperation: complications associated with the anterior approach (intraoperatively) were 3 venous lesions which were sutured immediately and caused minimal bleeding.In 2 patients, one pedicle screw was misplaced causing radicular pain and necessitating a second operation a few days after the initial surgery (2/56 patients (3.6%) and 2/272 pedicle screws (0.7%)).It was possible to correctly place the two screws at the second operation.The two misplaced screws missed medially and did not cause muscle weakness or paralysis.1 postoperative renal dysfunction registered ¿ normalized with fluid therapy after a few days.1 rupture of the rectus abdominis and transverse fascia which needed mesh augmentation (a reoperation).16 patients had complications beyond perioperative period and through the follow-up period: 1 loose pedicle screw was removed.1 superficial infection of the anterior incision was treated successfully with debridement and antibiotics.4 relaxations/paresis of the left rectus abdominis musculature were registered.1 posterior deep infection was treated successfully with removal of the pedicle screws and rods on one side and debridement and antibiotics for 6 weeks.In 7 cases, the posterior instrumentation was removed after 1 year because of possible discomfort and pain related to the posterior instrumentation ¿ these reoperations were not indicated because of implant loosening, implant failure or non-union or infection.The removal of the posterior instrumentation did not result in a change in the complaints of these patients and we do not consider the removal as a complication to the surgical procedure.2 adjacent level degenerations were registered in the same period and were treated with fusion ± decompression at the level in question.This is for unknown mono/polyaxial screws.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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 MONO/POLYAXIAL SCREWS
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• 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: 13967079
• MDR Text Key: 288309370
• Report Number: 1526439-2022-00511
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

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: 03/01/2022
• Initial Date FDA Received: 03/31/2022
• 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
• Patient Outcome(s): Required Intervention