MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM OPEN/CLOSED CONNECTOR 4.5 X 4.5MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 186172345S

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent a rod lengthening procedure.The surgeon had used two 1861-72-345 in their implant construct during the first installation procedure.This was the 5th lengthening, and the surgeons had some issues when attempting to loosen the domino nut to perform distraction.There was some friction caused between the nut and the domino, causing the threads to spoil when attempting to loosen.The surgeon commented that ¿the groove between the nut and shaft interface is too shallow, hence allowing for the domino nut to spoil¿.Due to this problem, the surgeons opted not to proceed with the distraction.They did not attempt to loosen the other screw as it may cause the construct to be unstable if both the domino nut threads are worn out.The surgery was delayed by 15 minutes, and the procedure was not successfully completed.The patient was discharged day 1 post-op, and they were doing fine.As of now, there are no plans for another round of revision.No further information is available.This report involves one expedium spine system open/closed connector 4.5 x 4.5mm.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.Additional device product codes: mni, kwq, osh, nkb, mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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.

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: video investigation: the video was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device video.Visual analysis of the video revealed that the screw exp 4.5 ti op/clsd 4.5x4.5 was attempting to loosen up with the screwdriver, however, with the evidence provided it was not possible determine if the threads of the screw were damaged or present any defect.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for exp 4.5 ti op/clsd 4.5x4.5.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: e1: initial reporter phone number added d4: udi number updated.Product was not returned.Based on the information available, it has been determined that no corrective and 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 OPEN/CLOSED CONNECTOR 4.5 X 4.5MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 16008211
• MDR Text Key: 305785468
• Report Number: 1526439-2022-02175
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034406183
• UDI-Public: (01)10705034406183
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 186172345S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• 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
• Treatment: EXP 4.5 TI OP/CLSD 4.5X4.5
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female