MAUDE Adverse Event Report: SYNTHES BRANDYWINE 6.0MM TI HARD ROD 75MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.103

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Disorder (2373); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported that the patient had a nonunion, adjacent level degenerative disease above and below the original construct and had a broken rod from a surgery that was performed on (b)(6), 2011.The rod broke at an unknown time.During the revision surgery on (b)(6), 2014, the tip of a variable axis screw iii screwdriver broke off in the screw.The patient had a l3-l5 posterior spine fusion with titanium universal spine system on (b)(6), 2011.At an unknown point in time, the patient saw the surgeon for increasing back pain.The surgeon assessed that the patient had a nonunion at l4-l5, and also had developed adjacent level degeneration at the l2-l3 and l5-s1 level that may be responsible for his pain.The broken rod was not discovered until the revision surgery on (b)(6), 2014.For the revision surgery the surgeon removed all of the universal spine system hardware and discovered the left rod was broken.The surgeon then instrumented the patient with universal spine system dual opening from l2, l3, l4, l5, and s1.He then performed a spinal decompression.He then decided to replace the right l5 universal spine system dual opening screw with a universal spine system variable axis screw iii screw because the angle of the universal spine system dual opening screw would not permit it to be connected to the rod and needed a polyaxial screw.During the insertion of the universal spine system variable axis screw iii screw the tip of the screwdriver broke off in the hex of the screw.The surgeon then placed a short rod in the screw and connected it using a nut and collar and tightened it so the poly screw would be locked.He then used the counter torque sleeve to get the screw out using the rod.The surgeon then placed a new universal spine system variable axis screw iii 9.0 x 50mm screw on.He then connected the rods successfully and then placed his iliac screws, connected them, and successfully completed the procedure.The broken rod was between left l4 and l5 screws.Left l4 screw was a 7.0 x 55 mm screw and the left l5 screw was a 7.0 x 50mm screw.There was a twenty minute delay reported during the revision surgery.No patient harm was reported during the revision surgery.This is report 7 of 21 for (b)(4).

Manufacturer Narrative

Date of event: unknown.Common device name: additional product codes: mni, mnh, kwp, kwq.Device history records indicate that the reported product was manufactured in accordance with all established requirements and procedures with no deviations reported.Device history records of the reported finished goods lot further indicate that the product lot underwent all required inspection operations and was found to meet all established criteria for release to warehouse, with no product nonconformities reported.Device history records of the reported product indicate that the raw material underwent all established inspection and test requirements and was found to meet all established specifications.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: 6.0MM TI HARD ROD 75MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3946002
• MDR Text Key: 4642777
• Report Number: 2530088-2014-10187
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.103
• Device Lot Number: 6430545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109