MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI 3-D HEAD FOR TI CLICK'X® SCREWS; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	498.571
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-codes: mni, nkb, kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.The reported event required medical/surgical intervention to preclude permanent damage to a body structure.For surgical intervention, medical device removal and pain.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 mexico as follows:it was reported that on (b)(6) 2019, the patient underwent a revision surgery instability of the column system.The surgeon mentioned that four (4) clickx locking caps were loosened and two (2) clickx 3d head for pedicle screws were detached from the shank of the screw causing an instability of the fixation system.An x-ray was taken and it was seen that the four (4) clickx locking cap had left the system and two (2) clickx 3d head for pedicle screw were thrown out.The whole system was removed.Initially, the patient underwent a lumbar canal secondary l5 s1 radiculopathy plus release plus recalibration with a transpedicular click column system on (b)(6) 2019.It was mentioned that they placed revision screw or larger diameter screws to complete the procedure.There was no surgical delay.The procedure was successfully completed.The patient was good and well.This complaint involves six (6) devices.This report is 1 of 6 for (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.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
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.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.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.Part: 498.571.Lot: 1l95228.Manufacturing site: mezzovico.Release to warehouse date: 12.Oct.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: TI 3-D HEAD FOR TI CLICK'X® SCREWS
• Common Device Name: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8575978
• Report Number: 8030965-2019-63424
• Device Sequence Number: 16740856
• Product Code: MNH
• UDI-Device Identifier: 10705034791098
• UDI-Public: (01)10705034791098
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K992739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2019

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: 498.571
• Device Catalogue Number: 498.571
• Device Lot Number: 1L95228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/22/2019; 06/24/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/18/2019; 06/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR