MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM PARALLEL ROD CONNECTOR DIAMETER 3.5-4.0 TO 5.5-6.35MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 102015083S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

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: e1: initial reporter is j&j company representative.H3, h6: 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 synthes reports an event in japan as follows: it was reported that this was a posterior cervical fusion (c2-th3) performed on (b)(6) 2018.The details of the products used in the initial surgery are unknown.After the surgery, during follow-up, neurological symptoms were observed.The extension surgery was performed on (b)(6) 2024, due to c1 cervical spondylosis.The discectomy was performed and an occipital plate, rods, and connectors were added, and an extension procedure was performed to connect the rods to the rods from a previous fusion.In the surgery, when the connector in question was removed from the sterile bag, the screw of the connector was loose, and the momentum of opening the bag caused the screw to become filthy.Since the product in question could not be used, a spare product was used.The surgery was completed successfully with no surgical delay.No further information is available.This pc is related to pc-001548170 which reports the initial surgery and the extension surgery due to c1 cervical spondylosis.This pc reports the event occurred in the extension surgery performed on (b)(6) 2024.This report is for symphony oct system parallel rod connector diameter 3.5-4.0 to 5.5-6.35mm for (b)(4).

• Brand Name: SYMPHONY OCT SYSTEM PARALLEL ROD CONNECTOR DIAMETER 3.5-4.0 TO 5.5-6.35MM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18865736
• MDR Text Key: 337566504
• Report Number: 1526439-2024-01009
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034520780
• UDI-Public: (01)10705034520780
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102015083S
• Device Lot Number: 375268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1