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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - SYNFLATE/VBS POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH UNK - SYNFLATE/VBS POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - synflate/vbs/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is jnj representative. 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. (b)(4). 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 a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 87 patients (32 males, 55 females) for vbs implants against all other surgical cases recorded within the spine tango registry between 2004 and the specified date. Final registry report outcome description: general complications- postoperative surgical before discharge 1 cerebral, 1 death. 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 synthes vertecem cement. It captures the reported events of 1 hardware removal, 1 implant failure and 1 instability. This is report 4 of 6 for (b)(4).
 
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Brand NameUNK - SYNFLATE/VBS
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11212699
MDR Text Key228833974
Report Number8030965-2021-00517
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 12/28/2020
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 Received12/28/2020
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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