MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM CROSSCONNECTOR HEAD TO HEAD 30 TO 42MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 102023102S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent a posterior cervical fusion (c3-6).The procedure proceeded as planned, and final tightening of a rod was completed.After that, the surgeon planned to set a cross connector onto the screw at c5.The cross connector selected did not fit into the set screw at all, so a new cross connector of one size smaller was selected.The smaller sized connector would also not fit onto the set screw, so a bender was used to stretch the curved part of the cross connector.This made the connector unusable.Another cross connector of the smaller size was prepared and used.This connector was set at the proper position and final tightened.The procedure was completed successfully with under 30 minutes of delay.No further information is available.This report is for a symphony oct system crossconnector head to head 30 to 42mm.This is report 1 of 2 for (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: d2: additional procode: nkg.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.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.

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: h4 device history: a manufacturing record evaluation was performed for the finished device product code: 102023102s.Lot number : wy224511.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 01/12/2022.Manufacturing site:jabil le locle.Expiry date:31/10/2027.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: SYMPHONY OCT SYSTEM CROSSCONNECTOR HEAD TO HEAD 30 TO 42MM
• 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 ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17380929
• MDR Text Key: 319776008
• Report Number: 1526439-2023-01322
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034520155
• UDI-Public: (01)10705034520155
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102023102S
• Device Lot Number: WY224511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CROSSCONN H2H 20 TO 30MM