MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, ST; PROBE

Catalog Number 279702030

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reporting during l4-s1 tlif dr.(b)(6) was cannulating the first pedicle at right l4 using the straight expedium pedicle probe.Bone was very hard.When he twisted to pull out probe it broke off in the patients pedicle.The broken tip was not retrieved.Dr.(b)(6) did not continue with tlif and only did a decompression.If other, describe.L4-s1.Was surgery delayed due to the reported event? no.Action taken when event occurred? went to look for some way to remove.Was procedure successfully completed? unknown.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.If no, explain.Dr.(b)(6) chose to not do the tlif and only did a decompression.Left the tip of the pedicle probe in.No way to retrieve.Patient status/ outcome / consequences? unknown.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? na.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? unknown.Other information: very heavy african american male.Possible (b)(6) 6¿2.Is the patient part of a clinical study? unknown.

Manufacturer Narrative

Product complaint #
=
> (b)(4).

• Brand Name: XPDM THORACIC PEDICLE PRB, ST
• Type of Device: PROBE
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8413423
• MDR Text Key: 138640020
• Report Number: 1526439-2019-51442
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 279702030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/29/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR