MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI CLICK'X LOCKING CAP FOR TI 3-D HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	498.570
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: mnh, mni, kwp, kwq.Complainant part is not expected to be returned for manufacturer review / investigation.(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 or Problem 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) 3.5 mm 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.(b)(4).
Additional 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.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.
Additional 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.Additional narrative: date of report: updated awareness date to: (b)(6) 2019, reported on initial as (b)(6) 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.

• Brand Name: TI CLICK'X LOCKING CAP FOR TI 3-D HEAD
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9197823
• Report Number: 8030965-2019-69365
• Device Sequence Number: 447453
• Product Code: NKB
• UDI-Device Identifier: 10705034791081
• UDI-Public: (01)10705034791081
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 498.570
• Device Catalogue Number: 498.570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 11/22/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/14/2019; 12/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention