MAUDE Adverse Event Report: SYNTHES MEZZOVICO 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.989

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: mni, mnh, kwp, kwq.Lot number 8220481 provided; it is unknown if it belongs to one of the complained screws.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a valid 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 the patient was implanted with a transpedicular fixation system at l4-l5 on (b)(6) 2013.During another procedure it was observed that the left screw at l4 was broken from the base, the left screw at l5 was broken from the medial portion, and the right screw was broken in the preassembled cap area.During the explant surgery of the system a screw half from one of the broken screws was left inside the patient; the rest of the hardware was removed from the patient.In addition it was noted there was a brownish black substance in the region where the screws and rods were placed on the right side.No prolongation of the explant surgery was reported.This is report 1 of 10 for (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.

Event Description

It was reported the patient visited the doctor because she felt pain; the surgeon scheduled the reoperation.

Manufacturer Narrative

A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Updated device history record review: manufacturing location: (b)(4) - manufacturing date: may 29, 2012.No non-conformance reports 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 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

Manufacturing investigation evaluation: four (4) click'x pedicle screws were returned with relative locking caps and two (2) rods in a mini-grip.One (1) screw is broken at the level of the shaft and other is broken off under the screw head.The detached portions of the screws were not returned.Additionally, the screws were not etched; therefore, it is not possible to associate the screw with the correct lot number.For this reason, the product inspection includes the analysis of both pedicle screws.The returned screws were inspected for the features in scope with this complaint.The screw indicated as screw "a" broke off in correspondence with the screw head.The screw head is inside the locking cap and cannot be measured.As a result, no conclusions could be drawn about the conformity of the screw.The second screw indicated as screw "b" broke off at the level of the shaft.It was possible to measure this part and no anomalies during the manufacture of the product were found.All the features were in-scope and measured within specifications.The screw is conforming from a manufacturing perspective.Considering that all relevant and measurable product features met specifications with no manufacturing-related visual defects, and considering that no anomalies were identified during production, the conclusion of the product investigation is that the returned parts were conforming from a manufacturing perspective.The complaint disposition is confirmed due to evidence that the two pedicle screws were broken, but it is considered invalid for (b)(4) as there is no evidence of issues manufacturing related.Product investigation summary: without further clinical information, the exact cause of the device breakage cannot be determined.The complaint is determined not to be a result of a detected product related deficiency.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 PREASSEMBLED 45MM THRD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA 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: 5631529
• MDR Text Key: 44402977
• Report Number: 2520274-2016-12531
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.989
• Device Lot Number: 7925131
• Other Device ID Number: (01)07611819113060(10)7925131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 68