MAUDE Adverse Event Report: SYNTHES USA 6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.645

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: mnh, mni, kwq, kwp0 (b)(4) lot unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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

It was reported that patient underwent revision surgery due to back pain, nonunion, and device loosening on (b)(6) 2016.The patient was initially implanted with synthes universal spine system (uss) variable axis screw (vas) system at l1-l2 on unknown date for unknown reason.Patient was implanted with four (4) uss vas screws, two (2) rods, four (4) titanium (ti) collar for uss vas, four (4) ti nuts, and one (1) ti low profile transconnector.The patient was then implanted with synthes matrix pedicle screw system at l4-l5 in 2015 (exact date unknown) for unknown reason.The patient was implanted with four (4) 6.0mm ti matrix polyaxial screws, two (2) cobalt chrome rods, four (4) matrix locking caps without saddle, and one (1) ti snap-on transconnector.The patient reported back pain on unknown date.The patient had postoperative imaging taken on unknown date; it is unknown if it was a scheduled visit.X-rays and computerized tomography (ct) scans confirmed a nonunion at l4-l5 and that the l5 screws loosened in the pedicle in the vertebral body.Imaging showed that all devices were intact.The patient returned to the operating room for hardware removal and revision surgery on (b)(6) 2016.It was surgeon preference to remove all existing hardware and performed a posterior fusion with new a matrix pedicle screw system at t10-s1.Reason for the level expansion is unknown.All existing hardware was easily removed without additional intervention.All hardware was intact.There was an intra-operative issue that is being captured in linked (b)(4).Concomitant devices reported: 6.2mm ti uss variable axis screw 50mm thread length (part 499.345, lot unknown, quantity 4); rods (part 498.1xx, lot unknown, quantity 2); ti collar for uss variable axis screws (part 497.140, lot unknown, quantity 4); ti nut 11mm width across flats (part 498.003, lot unknown, quantity 4); transconnector (part/lot unknown, quantity 1); 6.0mm ti matrix polyaxial screw 45mm thread length (part 04.632.645, lot unknown, quantity 2); rods (part 09.636.0xx, lot unknown, quantity 2); matrix locking cap without saddle (part 09.632.099, lot unknown, quantity 4); ti snap-on transconnector 38mm-47mm for 5.5mm/6.0mm rods (part 04.633.338, lot unknown, quantity 1).This is report 2 of 2 for (b)(4).

• Brand Name: 6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1032 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6152389
• MDR Text Key: 61656326
• Report Number: 2520274-2016-15620
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100952
• 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
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• 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
• Treatment: 1 PART04.633.338,LOTUNKNOWN,SNAP-ONTRANSCONNECTOR; 1 UNKNOWN TRANSCONNECTOR; 2 PART 09.636.0XX, LOT UNKNOWN, RODS; 2 PART 498.1XX, LOT UNKNOWN, RODS; 2 PART04.632.645,LOTUNKNOWN,MATRIXPOLYAXIALSCREWS; 4 PART 09.632.099, LOT UNKNOWN, MATRIX LOCKING CAP; 4 PART 497.140, LOT UNKNOWN, TI COLLAR; 4 PART 498.003, LOT UNKNOWN, TI NUT; 4 PART 499.345,LOT UNKNOWN,USS VARIABLE AXIS SCREW
• Patient Outcome(s): Required Intervention