MAUDE Adverse Event Report: SYNTHES MEZZOVICO 6.2MM TI CLICK'X® PEDICLE SCR DUAL CORE 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.562

Device Problem Fitting Problem (2183)

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

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Patient weight is unknown.Additional product codes for this report include: mni, mnh, kwp, and kwq.Implant and explant dates: device was not implanted or explanted during the procedure on (b)(6) 2016.Initial reporter last name is unknown.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: may 31, 2010 no non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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

It was reported that a patient underwent a spine lumbar revision procedure on (b)(6) 2016 due to a diagnosis of adjacent level disc disease (unknown level).During the revision, which utilized an evaluation set for the click'x spine system, both implant and instrument malfunctions occurred.Following the successful insertion of the screws, the 3-d heads were inserted.However, the insertion tool's release button would not click in order to fully release.It appeared to the surgeon that the 3-d head's were in place even though the instrument would not function as expected.Additionally, as the rod was being inserted at t9 (on the left side), the top screw head would not hold.The head wound up becoming loose and falling off.The surgeon then checked the other heads, discovering that they were all loose and easily removed.A removal tool, though typically required, was not needed for removal.Ultimately, all screws and 3-d heads inserted during this procedure were removed and replaced with preassembled screw-head constructs from a back-up set.A fifteen (15) minute surgical delay was noted as a result of having to switch out all of the screws.No additional medical intervention was required.The patient's post-operative status was unknown.Note: all of the original hardware from the initial procedure, which was performed over seven (7) years ago at left l2-s1, remained in the patient.The revision procedure extended the instrumentation/hardware to t9-l1.Concomitant device(s) reported: rod (part/lot: unknown / quantity: 1).This report will address the intra-operative issues only.The reason for revision will be captured in and reported under linked complaint (b)(4).This report is 20 of 20 for (b)(4).

Manufacturer Narrative

Product investigation summary: a visual inspection, functional test, and drawing review were performed as part of this investigation.It was reported that 3-d heads were unable to be fully attached to implanted pedicle screws.The returned implants were examined and no defects or deficiencies were identified that could have contributed to the complaint condition.Four (4) pedicle screws/3-d heads were received assembled and the remaining six (6) screws/3-d heads were received separate.As no deficiencies were identified, no further investigation will be completed.The returned positioning holders are a component of the click¿x posterior pedicle screw fixation system and are utilized to attach 3-d heads following screw body implantation.The devices were examined and the complaint condition was unable to be confirmed as the instruments were found to operate as intended.Each positioning holder was able to be used to attach one of the returned 3-d head to one of the returned pedicle screws.As each instrument was found to function as intended, and since the complaint condition was unable to be replicated, the complaint is unconfirmed.A device history record review was performed for the returned devices¿ lot numbers with no material record reports, non-conformance reports, or complaint-related issues identified during manufacture.The relevant drawings for the returned instruments were reviewed (both current revision and from the time of manufacture): top-level.The design, materials, and finishing processes were found to be appropriate for the intended use of this device.No root cause was identified as the complaint condition was unable to be replicated; as such, no further action is necessary.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Device 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: 6.2MM TI CLICK'X® PEDICLE SCR DUAL CORE 40MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5815983
• MDR Text Key: 50305620
• Report Number: 1000562954-2016-10160
• Device Sequence Number: 1
• Product Code: NKB
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.562
• Device Lot Number: 3460357
• Other Device ID Number: (01)10705034791029(10)3460357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR