MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; IMPLANT, FIXATION DEVICE, SPINAL

Catalog Number UNK_SPN

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/11/2022

Event Type  Injury  

Event Description

A patient was implanted with "transpedicular fixation of the spine." approximately seven months later, the patient was in a severe car accident.The next day the patient was experiencing pain and went to the emergency room where they were treated for leg injuries resulting from the accident.The patient also reports experiencing back pain at this time.The patient later underwent imaging and the x-ray showed a screw fracture at the left side s1.The patient was revised on approximately two months after the accident, underwent rehabilitation, and was seen by a neurologist.

Manufacturer Narrative

Device location unknown.

Manufacturer Narrative

The device was not returned for evaluation.The device was not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Per xia ii surgical technique: postoperative care: surgeons must instruct patients regarding appropriate and restricted activities during consolidation and maturation for the fusion mass in order to prevent placing excessive stress on the implants which may lead to fixation or implant failure and accompanying clinical problems.Surgeons must instruct patients to report any unusual changes of the operative site to his/her physician.The physician should closely monitor the patient if a change at the site has been detected.It is possible that the device fractured due to the reported trauma (car accident).However, based on the available information, a conclusive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

Event Description

A patient was implanted with "transpedicular fixation of the spine." approximately seven months later, the patient was in a severe car accident.The next day the patient was experiencing pain and went to the emergency room where they were treated for leg injuries resulting from the accident.The patient also reports experiencing back pain at this time.The patient later underwent imaging and the x-ray showed a screw fracture at the left side s1.The patient was revised on approximately two months after the accident, underwent rehabilitation, and was seen by a neurologist.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13725403
• MDR Text Key: 287021939
• Report Number: 0009617544-2022-00029
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention