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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC SKY SELF CENTERING AWL

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DEPUY SPINE INC SKY SELF CENTERING AWL Back to Search Results
Model Number 286820400
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results.
 
Event Description
Self centering awl tip broke when pressure was applied to the anterior aspect of vertebral body. Patient consequence? no.
 
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Brand NameSKY SELF CENTERING AWL
Type of DeviceAWL
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7646509
MDR Text Key112898458
Report Number1526439-2018-50611
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286820400
Device Catalogue Number286820400
Device Lot Number0406V
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 Received07/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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