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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH CERVIOS CURVED SIZ 6 PEEK POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH CERVIOS CURVED SIZ 6 PEEK POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 889.932S
Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or SeparationProblem (2906); Material Integrity Problem (2978); No Apparent Adverse Event (3189)
Patient Problems Injury (2348); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown synflate/vbs /unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 during a kyphoplasty on (b)(6) 2020, the tip of the side hole needle broke off and remained in the patient. The plan was to position the amschidi needle again and despite of low pressure from the surgeon, the tip of the pedicle broke off. This report is for an unknown synflate/vbs. This is report 1 of 1 for (b)(4).
 
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Brand NameCERVIOS CURVED SIZ 6 PEEK
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10795403
MDR Text Key217362436
Report Number8030965-2020-08679
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup,Followup,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number889.932S
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 Received01/08/2021
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: 11/05/2020 Patient Sequence Number: 1
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