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

Model Number	188311012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Event or Problem 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 3.5 x 5.5, 600.This is report 1 of 11 for (b)(4).
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for dual diameter rod 3.5 x 5.5, 600 was conducted identifying that lot number 8683n was released in a single batch.Batch 1: lot qty of (b)(4) units were released on 09 jun 2010 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

• Brand Name: DUAL DIAMETER ROD 3.5X5.5, 600
• Common Device Name: 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: 12814136
• Report Number: 1526439-2021-02388
• Device Sequence Number: 12133753
• Product Code: NKG
• UDI-Device Identifier: 10705034156606
• UDI-Public: 10705034156606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 188311012
• Device Catalogue Number: 188311012
• Device Lot Number: 8683N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown