MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM ADJUSTABLE ROD TITANIUM ALLOY DIAMETER 4.0 TO 4.0X220MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 1020-74-220S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Drug Resistant Bacterial Infection (4553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp.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: on (b)(6) 2021, a patient underwent a primary posterior cervical fusion in the occipital bone and the procedure was completed without surgical delay.On (b)(6) 2022, the surgeon reported that the rod might have come off, and a revision procedure was scheduled for (b)(6) 2022.It was reported that during the revision procedure on (b)(6) 2022, the surgeon commented that the setscrews on both ends of the plate had come off, and that the rod was about to protrude from the occipital region.This report is for a symphony oct system adjustable rod titanium alloy diameter 4.0 to 4.0x220mm.This is report 1 of 2 for (b)(4).Additional reports are captured under (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: event description updated d3: manufacturer email address added e1: initial reporter's phone number added h6 a manufacturing record evaluation was performed for the finished device product code: 102074220s lot number: rl287627 it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 13.10.2020 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

Mrsa infection is confirmed.The surgeon commented that the patient¿s son is on the verge of suing for lack of explanation from the manufacturer about implant problem.

• Brand Name: SYMPHONY OCT SYSTEM ADJUSTABLE ROD TITANIUM ALLOY DIAMETER 4.0 TO 4.0X220MM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14690183
• MDR Text Key: 294883042
• Report Number: 1526439-2022-00842
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034523637
• UDI-Public: (01)10705034523637
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181949
• 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,Followup

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: 1020-74-220S
• Device Catalogue Number: 102074220S
• Device Lot Number: RL287627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female