MAUDE Adverse Event Report: STRYKER SPINE-US 9MM X 6DEG X 9MM X 28MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48954096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devices remains implanted.
Event or Problem Description
It was discovered during patient monitoring that a tritanium pl cage fractured post-operatively.The patient has reported periodic pain in the lumbosacral region.Revision surgery will not be performed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that the cage fractured about 4 months after implantation at l5-s1.The device is currently still implanted.It was reported that there were no complications during the initial surgery.No x rays or images were provided.Disc distractions were performed according to standard procedure using the tritanium rasp-distractor.The implant was reported to have been implanted straight without turning in the disc space.Trials were used, disc space was reported to be low, but difficult to say if there was not enough space according to the site.Impactor was not used for final cage positioning and cage was not repositioned.Xia screws were used for supplemental fixation.Disc space compression was used in the final stage of the operation by standard technique.According to the reported information, no extreme maneuvers were done during the initial surgery.Without the device or x ray images, a definite cause cannot be determined.Possible causes include disc space being too tight causing excess force and possible fracture during insertion, patient anatomy, patient post op activity level or fall.
Event or Problem Description
It was discovered during patient monitoring that a tritanium pl cage fractured post-operatively.The patient has reported periodic pain in the lumbosacral region.Revision surgery will not be performed.

• Brand Name: 9MM X 6DEG X 9MM X 28MM
• 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: 10742782
• Report Number: 3004024955-2020-00039
• Device Sequence Number: 3385256
• Product Code: MAX
• UDI-Device Identifier: 07613327117967
• UDI-Public: 07613327117967
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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 Model Number: 48954096
• Device Catalogue Number: 48954096
• Device Lot Number: E94D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 97