MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Packaging Problem (3007)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is approximately one year ago additional device product codes: mni, mnh, kwp, kwq this report is for one (1) unknown end cap.Part and lot numbers are unknown.Without a specific part and lot numbers, the udi is not available.Device is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(510k): unknown, as specific part and lot numbers for end cap is not provided.Patient code (b)(4) is used as the package was missing an end cap which led to the surgeon putting in the screw without an end cap.The patient eventually needed a revision surgery prompted by a loosening screw.Without a lot number the device history records review could not be completed.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon performed a surgery approximately one year ago.The surgeon used a click'x pedicle screw but the implant box missed a blocker (end cap).As the patient was already anesthetized the surgeon decided to keep the procedure and left the screw without blocking.During the surgery on (b)(6) 2017 it was noted that the screw was loose.No information available about patient condition and outcome.This report is for one (1) unknown end cap.This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Upon receipt of the additional information this complaint was reviewed and it was detected that this reported device (locking cap) requires its own complaint.Therefore a new complaint (b)(4) has been opened and this report for locking cap is retracted and will be reported under the new complaint (b)(4).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.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6595495
• MDR Text Key: 76125745
• Report Number: 2520274-2017-11734
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• 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
• Patient Outcome(s): Required Intervention