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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT

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MEDOS INTERNATIONAL SàRL CH UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
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
Device report from synthes reports an event in the (b)(6) as follows: 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 may 1, 2012 and june 31, 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 : (source file 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 involves unknown biomaterial  cement. This is report 10 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).
 
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Brand NameUNKNOWN BIOMATERIAL - CEMENT
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL 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 Key11118360
MDR Text Key232338257
Report Number1526439-2021-00033
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/05/2021 Patient Sequence Number: 1
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