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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MEZZOVICO 6.2MM TI CLICK'X® PEDICLE SCR DUAL CORE 35MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES MEZZOVICO 6.2MM TI CLICK'X® PEDICLE SCR DUAL CORE 35MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 498.561
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
Additional narrative: patient identifier: (b)(6). Patient weight is unknown. Additional product codes for this report include: mni, mnh, kwp, and kwq. Device was not implanted or explanted during the procedure on (b)(6) 2016. 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 19, 2015. 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 17 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.
 
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Brand Name6.2MM TI CLICK'X® PEDICLE SCR DUAL CORE 35MM THREAD LENGTH
Type of DeviceORTHOSIS, 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 Key5815886
MDR Text Key50295361
Report Number1000562954-2016-10157
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number498.561
Device Lot Number9489961
Other Device ID Number(01)10705034791012(10)9489961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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