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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT
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DEPUY SPINE INC UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Device Problem Chemical Problem (2893)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown biomaterial - 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 on an unknown date that the confidence 7.Cement was mixed and refueled in hydraulic syringe.After the handle of hydraulic pump was rotated by surgeon, liquid permeated in the cement.This report is for one unknown biomaterial - cement.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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) and video provided.The image(s) were reviewed, and the complaint condition could not be confirmed, the setting time for the cement cannot be confirmed in the provided images.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information however it was noticed in the video that there is a small stream of leakage but that does not confirm the complaint allegation of improper cement setting time.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
Procedure was completed successfully with a delay of ten (10) minutes.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
 
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Brand Name
UNKNOWN BIOMATERIAL - CEMENT
Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key9668110
MDR Text Key178226831
Report Number1526439-2020-00494
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
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received02/04/2020
Supplement Dates Manufacturer Received02/20/2020
03/05/2020
Supplement Dates FDA Received02/21/2020
03/31/2020
Patient Sequence Number1
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