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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 Problems Failure of Implant (1924); Nerve Damage (1979); Decreased Sensitivity (2683)
Event Type  Injury  
Manufacturer Narrative
Additional 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. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Patient code (b)(4) used to capture additional medical/surgical intervention required. 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 (b)(6) as follows: this report is being filed after the review of spine tango registry report: implant report for depuy synthes vbs implants: euro spine tango (2020),spine tango registry, pages 1-40 ((b)(6)). This report aims to compare usage and outcomes recorded for vbs implants against all other surgical cases recorded within the spine tango registry. Between 16 january 2012 and 30 november 2020, a total of 292 patients (148 males, 145 females) were evaluated to compare usage and outcomes for vbs implants against all other surgical cases recorded within the spine tango registry. The following complications were reported: general complications- postoperative surgical before discharge: 1 death. General complications- postoperative surgical before discharge: 1 cerebral. Surgical complications- intraoperative adverse events: 2 other. Surgical complications- postoperative surgical before discharge: 1 radiculopathy, 1 motor dysfunction, 1 sensory dysfunction. Reoperations : number of reoperations at any level (9): 1 failure to reach therapeutic goals, 1 hardware removal, 1 implant failure,1 instability, 7 unknown. This is for depuy spine confidence cement. This complaint involves one (1) device. Related product complaint: (b)(4). This is report 1 of 1 for (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
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11215800
MDR Text Key233344472
Report Number1526439-2021-00176
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/22/2021 Patient Sequence Number: 1
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