MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CLICKX LOCKCAP T25 TAN; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.606.000

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procodes: mnh, mni, kwp, kwq.Complainant part is not expected to be returned for manufacturer review/ investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent a level s1 lumbar arthrodesis revision surgery due to implant failure.It was determined on an unknown date that all the locking caps and bars had became loose from the original operation.This included five (5) clickx locking caps, three (3) 3.5mm clickx locking caps, eight (8) unknown clickx screws and two (2) unknown bars.There was a surgical delay of fifteen (15) minutes.Procedure was successfully completed.Patient was stable.This is report 5 of 10 for (b)(4).This complaint is linked to (b)(4) and is related to the intraoperative event captured in (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Date of report: updated awareness date to: 10/9/2019, reported on initial as 9/27/2019.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: h3, h4, h6: 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.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: CLICKX LOCKCAP T25 TAN
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9197668
• MDR Text Key: 173185549
• Report Number: 8030965-2019-69363
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819937345
• UDI-Public: (01)07611819937345
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.606.000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention