MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ZERO PROFILE TWO-LEVEL ACP SIZE 28MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48660228

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

It was reported that; a piece of the gold locking mechanism on plate broke off.Not sure how it broke, doctor pulled out and said the piece broke off.

Manufacturer Narrative

Method: device inspection and device history review.Results: one device was confirmed to have a plate locking ring that fractured during implantation.No device inspection could be conducted because the plate remains implanted.Manufacturing records for this product could not be reviewed because no lot number was provided and the plate remains implanted.Conclusion: the probable root cause is unknown and multifactorial.

Event Description

It was reported that; a piece of the gold locking mechanism on plate broke off.Not sure how it broke, doctor pulled out and said the piece broke off.

• Brand Name: ZERO PROFILE TWO-LEVEL ACP SIZE 28MM
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4910327
• MDR Text Key: 6055874
• Report Number: 0009617544-2015-00318
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 48660228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2015
• 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