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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC. 5MM TAP, DUAL LEAD CANN STEREOTACTIC SURGERY SYSTEM PROBE, REUSABLE

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DEPUY SPINE INC. 5MM TAP, DUAL LEAD CANN STEREOTACTIC SURGERY SYSTEM PROBE, REUSABLE Back to Search Results
Model Number 286715500N
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 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. The lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. 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.
 
Event Description
This is report 1 of 2 for (b)(4). It was reported that by the sales rep that during a spinal fusion procedure on (b)(6) 2022, while tapping for a pedical screw, it was observed that the 6mm tap snapped by 1 cm from the tip while removing it from the bone. According to the report, while tapping another pedical with a 5mm tap, it was observed that the tap snapped 1 cm from the tip while removing it. All the fragments were removed. There was a surgical delay of two hours. There were no adverse patient consequences reported. No additional information was provided. This report is for one (1) 5mm tap, dual lead cann device. This complaint involves two (2) devices.
 
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Brand Name5MM TAP, DUAL LEAD CANN
Type of DeviceSTEREOTACTIC SURGERY SYSTEM PROBE, REUSABLE
Manufacturer (Section D)
DEPUY SPINE INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key14253246
MDR Text Key290446873
Report Number1526439-2022-00642
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120867
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286715500N
Device Catalogue Number286715500N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2022
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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