MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown biomaterial - cement/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 a clinical evaluation report (cer) from a related research activity database (ddra) for 3,766 patients who were identified in the text fields of the bsr database between (b)(6) 2012 and (b)(6) 2020 who had posterior stabilization procedures of the spine and/or pelvis with the expedium system.There were slightly more female (59.1%) than male patients (40.9%).There were 1,385 patients under the age of 19 (range: 2-18) in the study cohort.Among these pediatric patients,77 patients were between the ages of 2 and 9 and 1,308 patients were between ages 10 and 18.All other patients in the study cohort were over 18 years of age.The mean age of the study cohort was 39.9 years (sd 24.3).The expedium systems were not mutually exclusive across the study cohort, as some patients were implanted with more than one device family.All patients in the study cohort were implanted with the expedium system.Expedium fenestrated screws were identified in 18 patients.All 30 patients implanted with expedium growing spine had concomitant scoliosis diagnoses and were between the ages of 4 and 13.Additionally, of the 32 patients diagnosed with degenerative spine disease and instrumented in the cervical spine, nineteen patients were implanted with the synapse occipito-cervico-thoracic (oct) system [depuy synthes], five patients had the mountaineer oct system [depuy synthes], and one patient had cervifix [depuy synthes].The synapse oct system was also identified in one patient who was diagnosed with tumor.Cement augmentation was noted in 41 patients, of the study cohort.Cement augmentation was inclusive of both cemented screws and vertebral body augmentation.The expedium fenestrated screw system (device family c) is intended to be used with the confidence spinal cement system or the v-max mixing and delivery system and the vertebroplastic radiopaque resinous material or the vertecem v+ cement kit to provide immobilization and stabilization of spinal segmentsconfidence spinal cement [depuy synthes] was identified in one patient with a trauma diagnosis and one patient with a metastatic tumor diagnosis.Complications were noted in patients : (potential complaint form does not indicate which specific device is involved for the following allegation captured) 3 rod fracture, 7 screw loosening/displacement, 9 implant malposition, 4 implant-related failure, 5 non-union, 4 wound, 9 hematoma, excessive bleeding, 7 infection, 2 recurrent disc herniation, 1 radicular pain, 1 vertebral fracture, 43 dural tear, 6 cardiac complication, 2 lymphatic injury, 8 spinal cord/ nerve injury, 2 respiratory complication, 1 cement leakage, 1 recurrent deformity, 20 intraoperative neuromonitoring deficit.This is for unknown depuy spine expedium, expedium verse , expedium fenestrated expedium verse fenestrated,and expedium growing spine systems, mountaineer and confidence cement.This report is for one (1) unknown biomaterial ¿ cement.This is report 9 of 10 for (b)(4).This product complaint (b)(4), captures ten (10) of thirty-one (31) devices.The remaining devices are captured in (b)(4), (b)(4), and (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 11124861
• MDR Text Key: 233253399
• Report Number: 1526439-2021-00086
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• 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