MAUDE Adverse Event Report: DEPUY SPINE INC SPINAL SYSTEM ROD 3.5 X 60MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 188316060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2018 the primary posterior fusion at c3/4 was performed.On (b)(6) 2021 a revision procedure (depression and c3-c6 extension) was performed to treat an adjacent disorder.The surgeon confirmed that any product defectiveness was not the cause of the revision procedure.This report is for one (1) spinal system rod 3.5 x 60mm.This is report 1 of 3 for (b)(4).

• Brand Name: SPINAL SYSTEM ROD 3.5 X 60MM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12203775
• MDR Text Key: 262896602
• Report Number: 1526439-2021-01445
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034156965
• UDI-Public: 10705034156965
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 188316060
• Device Catalogue Number: 188316060
• Device Lot Number: BDLV7XF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention