MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SLOTTED CONNECTOR, MINI OFFSET LEFT 5.5/6.35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 175450055

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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

It was reported that on (b)(6) 2020 the patient presented with broken hardware, the expedium offset connector broke on the left side of the construct.A revision surgery was performed to replace the connector.The procedure and patient outcome are unknown.Concomitant devices: unknown setscrews (part# unknown, lot# unknown, quantity unknown ); unknown rods (part# unknown, lot# unknown, quantity unknown ).This report is for one (1) expedium spine system slotted connector, mini offset left 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: customer quality investigation: the iexp ddv ti slot conn mini l was not returned, and the investigation will be completed based on the supplied images.The images were reviewed, and the complaint condition was confirmed as the image showed the connector broken.As the connector was not returned an as received, dimensional, and material review were not applicable.Manufacturing record evaluation: a manufacturing record evaluation could not be performed as the lot number could not be determined from the provided image.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 SLOTTED CONNECTOR, MINI OFFSET LEFT 5.5/6.35MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10852384
• MDR Text Key: 216648597
• Report Number: 1526439-2020-02210
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034251752
• UDI-Public: 10705034251752
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175450055
• Device Catalogue Number: 175450055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Patient Outcome(s): Required Intervention