MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND SCREW DIA 5MMX 22MM STANDARD; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 49175022

Device Problems Mechanical Problem (1384); Dull, Blunt (2407); Mechanical Jam (2983)

Patient Problems Injury (2348); No Information (3190)

Event Date 11/09/2015

Event Type  Injury  

Event Description

It was reported that the patient had hard bone.Doctor indicated that after using punch awl and fixed awl the self tapping screw was too dull to advance in the bone.Used other product (not a styrker product) to complete the surgery.

Manufacturer Narrative

Method: risk assessment.Results: the device was not received back for evaluation and lot number not provided.Conclusion: the plausible root cause of the reported event could not be confirmed since the device was not received back.

Event Description

It was reported that the patient had hard bone.Doctor indicated that after using punch awl and fixed awl the self tapping screw was too dull to advance in the bone.Used other product (not a styrker product) to complete the surgery.

• Brand Name: SCREW DIA 5MMX 22MM STANDARD
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5273554
• MDR Text Key: 32894786
• Report Number: 3005525032-2015-00141
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 49175022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• 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