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

Catalog Number 04.614.508

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient age & weight not provided for reporting.Additional classification codes: kwp, mnh, mni.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Concomitant devices: therapy date: (b)(6) 2016.6x lockscr synapse tan: 04.614.508 / h36098, 2x rod ø4 l240 tan: 04.615.527s/ 9473080, 1x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.601s/ 9864100, 2x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.601s/ 9885229 - (reported in complaint), 2x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.018s/9885229 - (reported on the device report.2x cancellous bone screw synapse: 04.615.020s / h057490, 1x cancellous bone screw synapse : 04.615.022s/ 9830058, 2x occipital screw ø 4.5mm, l 12mm: 04.601.112/ 9664380.Reporters phone number: (b)(6).(b)(4).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4).Packaged by: (b)(4).Manufacturing date: 13-apr-2016.Part #: 04.614.508, lot#: h036098 (non-sterile) - ti locking screw.Qty: 244.Inspection sheet for incoming final inspection 04if614508 rev:k meet inspection acceptance criteria.Certificate of compliance received from general machine, inc.Meet specification.Components reviewed: bk100018 blank, 9.5mm ti w/t15 stardrive, 16mm long.Lot 9919154.Inspection sheet for incoming inspection t15it032 rev: e & certificate of compliance received from universal punch meet specification.No ncrs 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.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 two of eight locking screws migrated/dislocated postoperatively.Original implant date took place on (b)(6) 2016.Date of revision surgery is unknown.No information about patient outcome.This complaint involves 2 parts.Concomitant devices: 6x lockscr synapse tan: 04.614.508 / h36098, 2x rod ø4 l240 tan: 04.615.527s/ 9473080, 1x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.601s/ 9864100, 2x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.601s/ 9885229, 2x cancellous bone screw synapse: 04.615.020s / h057490, 1x cancellous bone screw synapse: 04.615.022s/ 9830058, 2x occipital screw ø 4.5mm, l 12mm: 04.601.112/ 9664380.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Concomitant devices: therapy date: (b)(6) 2016.This concomitant device report replaces the previous mw concomitant devices reported.6x lockscr synapse tan: 04.614.508 / h36098; 2x rod ø4 l240 tan: 04.615.527s/ 9473080; 1x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.601s/ 9864100; 1x cancellous bone screw synapse: 04.615.618s/ 9918401; 2x cancellous bone screw synapse: 04.615.618s/ 9885229; 2x cancellous bone screw synapse: 04.615.020s / h057490; 1x cancellous bone screw synapse : 04.615.022s/ 9830058; 2x occipital screw ø 4.5mm, l 12mm: 04.601.112/ 9664380.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.

Event Description

Update: 26jun2017, concomitant devices: 6x lockscr synapse tan: 04.614.508 / h36098; 2x rod ø4 l240 tan: 04.615.527s/ 9473080; 1x occipital-pl 4.5/5 med w/50 f/r ø4 ti: 04.615.601s/ 9864100; 1x cancellous bone screw synapse: 04.615.618s/ 9918401; 2x cancellous bone screw synapse: 04.615.618s/ 9885229; 2x cancellous bone screw synapse: 04.615.020s / h057490; 1x cancellous bone screw synapse : 04.615.022s/ 9830058; 2x occipital screw ø 4.5mm, l 12mm: 04.601.112/ 9664380.

Manufacturer Narrative

A product investigation was performed on the returned locking screws.This complaint is confirmed based on the review of the provided x-ray.Two loose locking screw caps can be observed in the x-ray, one from the synapse screw and second from the occipital plate.The complaint was replicated at the customer quality (cq) by performing functional testing.The locking screw caps (qty 7) were tried to be fitted into the heads of returned occipital plate and synapse screws.The locking caps could not be fully fitted in two synapse screws and one of the two rod clamps of the plate.The same locking caps would fit normally in the other screw heads.Minor wear marks on the threads of these synapse screws were observed.It is possible that these occurred during implantation-explantation of the implants.Visual inspection, dhr review, functional test, and drawing review were performed as part of this investigation.Total 8 locking screw caps (04.614.508) were returned with the complaint at cq location.The lot number for the 6 concomitant screw caps and 2 alleged screw caps is same.Although eight (8) locking caps were returned, only seven (7) were able to be located at the time of the investigation.All the locking screw caps were sent together in one packet and hence there was no way to identify exactly which two locking screw caps malfunctioned.If the missing locking cap is found in the future, the device will be investigated and investigation summary shall be updated accordingly.All the remaining seven locking screw caps were visually inspected and did not found to exhibit any damage that would interfere the device functionality.The 04.614.508 locking screws are utilized in the synapse oct system for posterior stabilization of the upper.The technique guide states that after final adjustment of the construct, fully tighten all locking screws with the screwdriver shaft and the 2 nm torque limiting handle.The construct is now rigidly locked.Final tightening should be accomplished after all locking screws have been placed, and should be aided by the countertorque tool.Relevant drawing for t15 drive set screw was reviewed.No product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned locking screw caps did not exhibit any damages that would impact the device functionality.Minor damages to the threads of these synapse screws were observed.This dents on the implant threads may have contributed to the loosening of the locking caps and could have also prevented locking caps initially from achieving fully seated position.It is not possible to tell if this damage occurred during implantation-explantation procedures or existed before the original implantation of the implants.Improper technique, use of excessive force may lead to the observed damage on the threads during operation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Further it was reported that the patient initially underwent occipito-cervical fusion with internal fixation on (b)(6) 2016.Patient was treated for an instable bilateral atlas arch fracture as well as posterior arch fracture c2 with radiation into the facet joints.Concomitant medical products: ti locking screw (part # 04.614.508, lot # h036098, quantity 6), 4.0mm ti rod 240mm (part # 04.615.527s, lot # 9473080, quantity 2), ti occipital plate-medial (part # 04.615.601s, lot # 9864100, quantity 1 ), cancellous bone screw synapse (part # 04.615.018s, lot # 9918401, quantity 1), cancellous bone screw synapse (part # 04.615.018s, lot # 9885229, quantity 2), 3.5mm ti cancellous polyaxial screw 20mm (part # 04.615.020s, lot # h057490, quantity 2), 3.5mm ti cancellous polyaxial screw 22mm (part # 04.615.022s, lot # 9830058, quantity 1), 4.5mm ti occipital screw 12mm (part # 04.601.112, lot # 9664380, quantity 2).

• 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: 6663687
• MDR Text Key: 78290882
• Report Number: 1719045-2017-10594
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819969599
• UDI-Public: (01)07611819969599(10)H036098
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Device Lot Number: H036098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention