MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM LATERAL OFFSET CONNECTOR DIAMETER4.0MM, LONG; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1020-21-402S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional 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.Additional procode: kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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 or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent a pcf for treating rheumatism.During the procedure, the surgeon needed to take different screw insertion approaches due to deformed bone areas from the rheumatism.The rod connections were difficult due to the complicated screw alignments, and two of the connectors did not fit.The procedure was completed with a delay of under 30 minutes.This report is for a symphony oct system lateral offset connector diameter4.0mm, long this is report 2 of 2 for (b)(4).

• Brand Name: SYMPHONY OCT SYSTEM LATERAL OFFSET CONNECTOR DIAMETER4.0MM, LONG
• Common Device Name: 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: 14889792
• Report Number: 1526439-2022-00980
• Device Sequence Number: 5150772
• Product Code: NKG
• UDI-Device Identifier: 10705034520353
• UDI-Public: (01)10705034520353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1020-21-402S
• Device Catalogue Number: 102021402S
• Device Lot Number: 284069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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: ANG LATERAL OFFSET CON 4.0
• Patient Sex: Unknown