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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

There are multiple patients.Pma/510k: this report is for an unknown cement/unknown lot.Part and lot number 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 (b)(6) reports an event as follows: it was reported that there were 73 subjects in this report for a total of 84 patient.11 patients were not included in this final report because there were no follow up data.Treatment for confidence was 59 patient, perimeter 14 patient, and was not reported for the 11 patients.Confidence group had 39 females and 20 males with a mean age of 69.8 years.Perimeter group had 13 females and 1 male with a mean age of 75.7 years.Medical history reported: allergies, cancer/malignancy, cardio/circulatory, dermatological, endocrine/metabolic, gastrointestinal, hematological, musculoskeletal, neurological, psychiatric, respiratory, urogenital, diabetes, and osteoporosis.Study enrollment started on (b)(6) 2010, the last enrollment was (b)(6) 2011, and the last completed visit follow up was completed on (b)(6) 2011.The levels treated were between t7-l5.Twenty-five percent if subjects treated with confidence experience cement leakage.Thirty-six percent of leakage in perimeter cases.Cement leakage: confidence: 16 patients: location 12 discal and 4 venous: severity: 8 mild, 3 moderate, 5 none.Perimeter: 5 patients: location 5 venous: severity: 3 mild, 1 moderate, 1 none.One subject from both confidence and perimeter treated subjects experienced a new fracture at the one month follow up.There were three serious adverse events reported in the study however, none of these were device related.There was no device related adverse events reported during the procedure for either confidence or perimeter.One adverse event was reported for the confidence study as a discal cement leakage that was not device related or serious and was resolved.Subject 252: cement leakage (malfunction only no adverse event reported).Subject 783: death: unrelated to device.This report is for an unknown cement.This is report 1 of 5 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 11893644
• MDR Text Key: 266933292
• Report Number: 1526439-2021-01050
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2012
• 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