MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number 498.570V

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

Patient¿s identifier and weight are not available for reporting.(b)(4).Due to the intra-operative issue, the device was not successfully explanted during the revision surgery performed on (b)(6) 2017.Second revision surgery was scheduled for (b)(6) 2017; however it is unknown if the revision surgery was completed on (b)(6) 2017 and if the device was explanted.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4) is used as the complaint indicated that the screw was being removed during a revision; however during removal it stripped and the procedure was not able to be completed.An additional revision procedure is needed to remove the stripped 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 europe reports an event in (b)(6) as follows: it was reported that a primary surgery for lumbar canal stenosis was performed using the click ¿x system on (b)(6) 2013.The fixation area was l3-l5.The initial surgery was completed successfully.Postoperatively patient was diagnosed with a neighboring intervertebral disk disorder.On (b)(6) 2017, the revision surgery was performed to replace the screw in use with a new one.During the revision surgery, the hexagonal hole of click¿ x locking cap was stripped when the surgeon tried to use 3.5mm hexagonal screwdriver with t-handle and eventually failed to remove the screw sitting at l4 (left).He tried to cut the rod by the rod cutter (non-j&j product) and the rod cutter broke.Eventually the surgery was suspended with a sixty (60) minute surgical delay after closing the incision.The revision surgery was scheduled again for (b)(6) 2017; however no further information has been provided regarding the revision surgery and the situation afterward.This report addresses intraoperative issue of locking cap stripping during removal.The postoperative issue of patient¿s diagnosis of neighboring intervertebral disk disorder has been reported under linked complaint (b)(4).Concomitant device reported: 3.5mm hexagonal screwdriver with t-handle (part # 314.131, lot # unknown, qty.1).This report is for one (1) ti click'x locking cap for ti 3-d head.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Updated concomitant device.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

Concomitant device reported: 3.5mm hexagonal screwdriver with t-handle (part # 314.131, lot # 1107780, qty.1).

Manufacturer Narrative

The complained part click¿x¿ locking cap - was not returned for investigation and the exact lot number is not known the present complaint cannot be fully analyzed and we are not able to give a conclusive statement.Based on the information available, 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.The following part was returned as concomitant device without an alleged complaint condition ¿ one screwdriver, hexagonal, ø 3.5mm, w/t-handle (314.131, lot 1107780).Upon visual inspection, no evidence was found that would cause or contribute to the reported complaint condition.Instrument presents normal signs of use but no damage.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

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

Additional concomitant device reported: unknown pedicle screw (part# unknown, lot# unknown, quantity 1).

• Brand Name: TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD
• Type of Device: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6812999
• MDR Text Key: 83463767
• Report Number: 1000562954-2017-10189
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082572
• 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,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.570V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2017
• 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
• Patient Age: 69 YR