MAUDE Adverse Event Report: SYNTHES MONUMENT TI LOCKING SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: kwp, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number is not provided for reporting.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that the initial surgery for ossification of posterior longitudinal ligament was performed using the synapse 4.0 system on (b)(6) 2017.The fixed area was c2 - c7.On (b)(6) 2017, the surgeon confirmed that the locking screw, which was implanted in the distal part of left side, had been pulled out after the surgery from the original position.Per surgeon this might be caused by the incomplete tightening.The revision surgery was performed on (b)(6) 2017 to replace it with a new implant.The screw head was sitting at the location where the rod was bent, and was not in an upright position against the rod.As surgeon tried to get the screw head as upright as possible, he could properly set the locking screw into the screw head.The revision surgery was successfully completed.This report is for one (1) ti locking screw.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

A device history record (dhr) review was performed for part number: 04.614.508, synthes lot number: h274169, supplier lot number: na: release to warehouse date: 11-mar-2017, manufactured by: monument: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this products, and any subcomponents, which would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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

A manufacturing investigation action & summary was conducted/performed.The report indicates that: the part was sent to the manufacturer for investigation.Detailed investigation is documented.As received condition of device: dimensions and attributes of the part were conforming.The manufacturing investigation was completed to determine if the returned part was conforming to its drawing requirements.The inspection was documented on the attached inspection form and all dimensions were found to be conforming to drawing requirements.In conclusion, because the dimension and attributes of the part were found to be conforming, the manufacture of the part did not contribute to the complaint condition.No manufacturing related issue was identified and/or confirmed.We are not able to identify the root cause for the reported problem.The complaint is adequately addressed by the risk assessment.No indication for product related issue was found.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 LOCKING SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6987055
• MDR Text Key: 90604977
• Report Number: 1719045-2017-11127
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819969599
• UDI-Public: (01)07611819969599(10)H274169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Device Lot Number: H274169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention