MAUDE Adverse Event Report: SYNTHES MONUMENT TI LOCKING SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information reported.It is unknown when device malfunctions occurred.This report is for unconfirmed/unknown quantity of unknown locking caps (udi) no part number, udi unavailable.Original implant date(s) are unknown; it is unknown if the device(s) were explanted and if so what date the devices were explanted.Device(s) are unavailable for return.Unknown therapy date.Part # is unknown, 510k is unknown.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.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 surgeon identified a total of three (3) possible synapse locking cap failures in multiple unknown cases.It is unknown when the devices were implanted and when or if the devices were explanted.It was clarified that it was identified postoperatively that the devices loosened.Concomitant devices reported: synapse 4.0mm screws (part #: unknown, lot #: unknown, qty.Unknown); synapse 4.0mm rods (part #: unknown, lot #: unknown, qty.Unknown) this report is for unconfirmed unknown quantity of locking caps this is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Corrected data: additional device codes: kwp, mnh, mni.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 that a surgeon identified a total of three (3) possible synapse locking cap failures in multiple unknown cases.It was clarified that it was identified postoperatively that the devices loosened from the screw and either came off completely from the screw head, or loosened and slid off of the rod either cranially or caudally.Concomitant devices reported: synapse 4.0mm screws (partial part 04.615.Xxx, lot number unknown, quantity unknown); synapse 4.0mm rods (partial part 04.615.Xxx, lot number unknown, quantity unknown).

• Brand Name: TI LOCKING SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6629442
• MDR Text Key: 77538815
• Report Number: 2520274-2017-11784
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.614.508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1