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

Catalog Number 498.570

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/15/2017

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: mni, nkb, kwp, kwq device is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) is used to capture the removal and replacement of pedicle screw which resulted in 40 minutes surgical delay.Without a 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 (b)(4) reports an event in (b)(6) as follows: it was reported that during a spinal arthrodesis procedure, the click-x screw opened the head at the time of tightening the blocker (locking cap), preventing the final tightening.It is not known whether the screw head was already damaged before surgery.In order to replace the screw that was defective and located in the most cranial part on the left, it was necessary to remove the rod and consequently all the blockers.Then the rod and the respective blockers were inserted again.This resulted in a forty (40) minute surgical delay.There was no patient harm.Concomitant device reported: blockers (part #: unknown, lot #: unknown, quantity: 5), rod (part #: unknown, lot #: unknown, quantity: 1) this report is for one (1) ti click'x® locking cap for ti 3-d head this is report 2 of 2 for complaint (b)(4).

• 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
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7118978
• MDR Text Key: 94923743
• Report Number: 8030965-2017-50704
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07611819085404
• UDI-Public: (01)07611819085404(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR