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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; INTERVERTEBRAL BODY FUSION DEVICE
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STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Catalog Number UNK_SPN
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Impaired Healing (2378)
Event Date 04/17/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, the patient underwent a plif procedure, during which a pl cage was implanted.The patient reported back pain postoperatively and visited the hospital.Infection was suspected.Patient underwent a revision surgery on (b)(6) 2019, during which the surgeon noted the cage did not heal and could easily be removed.The surgeon removed the cage and placed the autologous bone in the ilium to complete the surgery.
 
Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.Complaint and device history records were not reviewed as a valid lot number was not provided and could not be obtained.It is unknown if there were any complications during initial procedure, no x rays are available and there was no medical intervention for the infection.There was no fusion, fall or post op trauma.No reported device malfunction for the tritanium pl cage.According to the ifu: "potential risks identified with the use of this intervertebral body fusion device, which may require additional surgery, include: device component fracture, loss of fixation, pseudoarthrosis (i.E.Non-union), fracture of the vertebrae, neurological injury, and vascular or visceral injury." the cage was implanted for a period of 2 months and the patient did not fuse.There was no reported failure of the tritanium pl cage.Non union can occur for any of the potential reasons outlined in the ifu.
 
Event Description
On (b)(6) 2019, the patient underwent a plif procedure, during which a pl cage was implanted.The patient reported back pain postoperatively and visited the hospital.Infection was suspected.Patient underwent a revision surgery on (b)(6) 2019, during which the surgeon noted the cage did not heal and could easily be removed.The surgeon removed the cage and placed the autologous bone in the ilium to complete the surgery.
 
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Brand Name
UNKNOWN_SPINE_PRODUCT
Type of Device
INTERVERTEBRAL BODY FUSION DEVICE
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key8601737
MDR Text Key144798084
Report Number3004024955-2019-00013
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
PMA/PMN Number
K160955
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SPN
Device Lot NumberUNK_SPN ASIS
Was Device Available for Evaluation? No
Date Manufacturer Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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