MAUDE Adverse Event Report: DEPUY SPINE INC DUAL DIAMETER ROD 3.5X5.5, 600; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 188311012

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: part # 188311012, lot # 8529n.Batch # 1 qty, (b)(4) release to warehouse date: (b)(4) 2020.No ncr's were generated during production.Product was not returned.Based on the information available, it has been determined that no corrective and 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) 2011, the patient underwent a cervical-thoracic posterior fusion (c4-t2 excluding c7) for ossification of posterior longitudinal ligament (opll).On (b)(6) 2021 the patient was diagnosed with adjacent segment disease (asd) which required decompression fusion between t2 and t3.All implants fused in 2011 had no defect so the fusion will be extended.The revision of c7, t3 (or up to t4) was planned for (b)(6) 2021.This report is for one (1) dual diameter rod 3.5x5.5, 600.This is report 2 of 11 for (b)(4).

• Brand Name: DUAL DIAMETER ROD 3.5X5.5, 600
• 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: 12814171
• MDR Text Key: 280772761
• Report Number: 1526439-2021-02389
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034156606
• UDI-Public: 10705034156606
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2021

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: 188311012
• Device Catalogue Number: 188311012
• Device Lot Number: 8529N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DUAL DIAMETER ROD 3.5X5.5, 600; MNTR F/A SCREW 4.0 DIA X 12; MNTR F/A SCREW 4.0 DIA X 14; MNTR F/A SCREW 4.0 DIA X 14; MNTR F/A SCREW 4.0 DIA X 16; MNTR F/A SCREW 4.0 DIA X 16; MNTR F/A SCREW 4.0 DIA X 16; SI POLYAXL SCREW 5 X 25MM; SI POLYAXL SCREW 5 X 30MM; SI POLYAXL SCREW 6 X 30MM
• Patient Outcome(s): Required Intervention