MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM VARIABLE OPEN/CLOSED PIVOTING CONNECTOR 5.5 X 5.5-6.35MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 179774555

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/21/2022

Event Type  malfunction  

Event Description

Device report from denmark reports an event as follows: it was reported that during a procedure on (b)(6) 2022, it was found that the small locking screw in the expedium connector could not be tightened.The small screw is wrongly placed in the thread.Other connectors were used, and the procedure was completed successfully with no surgical delay.There was no adverse patient outcome.This report is for a expedium spine system variable open/closed pivoting connector 5.5 x 5.5-6.35mm.This is report 1 of 1 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.Additional procodes: mni, nkb, kwq, kwp, osh.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: EXPEDIUM SPINE SYSTEM VARIABLE OPEN/CLOSED PIVOTING CONNECTOR 5.5 X 5.5-6.35MM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15069156
• MDR Text Key: 304698351
• Report Number: 1526439-2022-01249
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034078120
• UDI-Public: (01)10705034078120
• Combination Product (y/n): N
• PMA/PMN Number: K092626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• 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: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179774555
• Device Catalogue Number: 179774555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• 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