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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 Separation Problem (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).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Additional event information photos received attached.In addition, this medical info was received: during the kyphoplasty on (b)(6) 2020 the tip of the side-hole needle broke off in the patient.Not able to remove the broken tip.Surgeon wanted to position the amschidi needle again but the tip of the pedicle broke off.The patient was a 77 year old with an osteoporotic lumbar vertebrae 2 fracture.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The complaint condition, that the tip of the synflate wire is broken, could be confirmed according to the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and 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
The initial complaint was reviewed and found not reportable.Additional information indicates the incorrect product information was originally provided.There is no complaint against this device.The complaint is against device captured on depuy spine complaint (b)(4), and medwatch reports will be submitted from that complaint file.
 
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Brand Name
CERVIOS CURVED SIZ 6 PEEK
Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10795403
MDR Text Key217362436
Report Number8030965-2020-08679
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
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 Health Professional
Device Catalogue Number889.932S
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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