MAUDE Adverse Event Report: SYNTHES MEZZOVICO CLICKX LOCKCAP T25 TAN; ORTHOSIS, PEDICLE SPINAL FIXATION

Catalog Number 04.606.000

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that several click'x 3d-heads loosened from their pedicle screw counterparts postoperatively on level s1 left, s1 right, and l5 right.It is possible that the l5 left became loose as well, but it could not be seen during the explantation/revision procedure.The patient underwent an initial surgical procedure in 2012 on level l5, with an extension of the system onto s1 on (b)(6) 2014.The most recent procedure, a revision due to the loose 3d-heads, occurred on (b)(6) 2014.This report is 7 of 20 for (b)(4).

Manufacturer Narrative

Patient initials are (b)(6).Event date: unknown.Additional product codes for this report include: nkb, mnh, kwp, and kwq.Original implant was on an unknown day in 2012.An extension of the implant occurred on (b)(6) 2014.A revision procedure took place on (b)(6) 2014, but it is unknown if the entire device was explanted.Device is expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the usa.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history report: manufacturing location: (b)(4) - manufacturing date: april 15, 2014 - 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

Additional narrative: a product development evaluation was completed: parts are used and show normal wear and tear.Visual inspection shows no unusual tear or damage to the implants.Potential cause of the failure could have been the choice of screw for a reduction; click on screw instead of preassembled.No product related fault could be found.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

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

An image reading of the x-rays was conducted by a medical director from this manufacturer and reported the following: ¿i have looked at the multiple images (ct scans and x-rays).While it is difficult to tell with complete certainty due to the limited views and quality of images, the images do suggest, in accordance with the complaint narrative, that there is loosening of the heads from the screws in the two caudal levels of the construct, particularly appreciated at s1 level.¿.

Manufacturer Narrative

Additional 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.

• Brand Name: CLICKX LOCKCAP T25 TAN
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4417533
• MDR Text Key: 5421036
• Report Number: 1000562954-2015-10014
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.606.000
• Device Lot Number: 8949747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 88