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

Model Number 498.570

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: mni, nkb, kwp, kwq.Device remains implanted in patient; as such explant date is not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.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 during a surgery performed on (b)(6) 2017, the surgeon noted that the screwdriver available for use would not work with the click´x system + t-pal implants being placed in a patient.Reportedly, the patient was anesthetized and as the surgeon proceeded to place the six click´x screws he had to force the screwdriver so that the first screw was placed correctly and locked with the corresponding click x locking cap.The screwdriver did not work at all and the surgeon was unable to correctly secure the other five click x locking caps.Additionally reported, the surgeon received with the set, two straight rods and not two curved rods as expected.As such, he had to manually adapt the bar to fit the construct.The surgeon completed the surgery but only one locking cap was fit as expected, the other five did not fit (nor did the devices make the click sound as expected), the surgeon tried to fit as much as screwdriver allowed.The surgery was delayed by 45 minutes due to the intra-operative events.The patient was reportedly discharged from the clinic and is under periodic supervision.There have been no changes to the patient status and the implanted devices show now device malfunction or any adverse experience such as pain.Concomitant devices reported: 7.0mm ti click'x® pedicle screw preassembled 35mm thrd length (part # 498.994, lot number unknown, quantity 2), 6.2mm ti click'x® pedicle scr preassembled 45mm thrd length (part # 498.989, lot # unknown, quantity 4), ti click'x® locking cap for ti 3-d head (part # 498.570, lot # l227879, quantity 1).This report is for one (1) ti click'x® locking cap for ti 3-d head.(b)(4).

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.

Manufacturer Narrative

Patient age or date of birth not available for reporting.Dhr review was completed.Part no.: 498.570, lot no.: l227879, manufacturing location: (b)(4), release to warehouse date: 30.Nov.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
• Type of Device: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7196397
• MDR Text Key: 97871377
• Report Number: 8030965-2018-50400
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034791081
• UDI-Public: (01)10705034791081(10)L227879
• Combination Product (y/n): N
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 498.570
• Device Catalogue Number: 498.570
• Device Lot Number: L227879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 80