MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 11MM X 23MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48951096
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is currently still implanted in the patient.
Event or Problem Description
A physician reported that a tritanium pl cage placed at l5 to s1 was found to be fractured approximately one year after implantation.Patient has been experiencing, ¿some increase in axial pain.¿ revision surgery is not planned at this time; physician has scheduled a follow-up x-ray with the patient in three months.
Event or Problem Description
A physician reported that a tritanium pl cage placed at l5 to s1 was found to be fractured approximately one year after implantation.Patient has been experiencing, ¿some increase in axial pain.¿ revision surgery is not planned at this time; physician has scheduled a follow-up x-ray with the patient in three months.
Additional Manufacturer Narrative
Mfr name, city, and state (legal mfg) has been corrected from stryker spine cork to stryker spine us.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.It was confirmed via x-ray that the cage had fractured.No patient information was provided and it is unknown if the patient had any post op trauma.Patient has grade i spondy and is experiencing some increase in axial pain.Dr.(b)(6) (stryker employee) reviewed the x rays and confirmed the fracture and stated that the patient has a grade 2 spondy.Per surgical technique: the surgeon must discuss all physical and psychological limitations inherent to the use of the device with the patient.This includes the rehabilitation regimen, physical therapy, and wearing an appropriate orthosis as prescribed by the physician.Particular discussion should be directed to the issues of premature weight bearing, activity levels, and the necessity for periodic medical follow-up.The surgeon must warn the patient of the surgical risks and make them aware of possible adverse effects.The surgeon must warn the patient that the device cannot and does not replicate the flexibility, strength, reliability or durability of normal healthy bone, that the implant can break or become damaged as a result of strenuous activity or trauma, and that the device may need to be replaced in the future.If the patient is involved in an occupation or activity which applies inordinate stress upon the implant (e.G., substantial walking, running, lifting, or muscle strain) the surgeon must advise the patient that resultant forces can cause failure of the device.Delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/ nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) must be revised or removed immediately before serious injury occurs.Ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.The ddd patients may also have up to grade i spondylolisthesis at the involved level(s).These patients should be skeletally mature and have six months of nonoperative therapy.As the device was not returned, a definite root cause cannot be determined.Possible root causes include increased load due to patient anatomy (grade 2 spondy), and/or patient post op activity/fall.Device was also implanted for a year, which in the event that healing is delayed, does not occur, or failure to immobilize the delayed/ nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.A capa has been opened in order to determine the root cause(s) of this failure mode and implement actions to reduce occurrence.
Additional Manufacturer Narrative
G.4.Correction: reportability awareness date updated from (b)(6) 2019 to (b)(6) 2019.H.10.Updated from: stryker employee reviewed the x rays and confirmed the fracture and stated that the patient has a grade 2 spondy.As the device was not returned, a definite root cause cannot be determined.Possible root causes include increased load due to patient anatomy (grade 2 spondy), and/or patient post op activity/fall.To: it was confirmed via x-ray that the cage had fractured.No patient information was provided and it is unknown if the patient had any post op trauma.Patient has grade i spondy and is experiencing some increase in axial pain.As the device was not returned, a definite root cause cannot be determined.Possible root causes include increased load due to patient anatomy and/or patient post op activity/fall.
Event or Problem Description
A physician reported that a tritanium pl cage placed at l5 to s1 was found to be fractured approximately one year after implantation.Patient has been experiencing, ¿some increase in axial pain.¿ revision surgery is not planned at this time; physician has scheduled a follow-up x-ray with the patient in three months.

• Brand Name: 9MM X 6DEG X 11MM X 23MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9007945
• Report Number: 3004024955-2019-00037
• Device Sequence Number: 2733657
• Product Code: MAX
• UDI-Device Identifier: 07613327117561
• UDI-Public: 07613327117561
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2022
• Device Model Number: 48951096
• Device Catalogue Number: 48951096
• Device Lot Number: DMJ3
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 11/30/2019; 10/30/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 12/04/2019; 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1