MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 48651118

Device Problems Break (1069); Mechanical Problem (1384); Device Damaged by Another Device (2915)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

It was reported that they found the locking rings were broken and destroy the nail during surgery.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: manufacturing records for this product were reviewed and no anomalies were found.No manufacturing anomalies and it appears that the technique was followed.Conclusion: a root cause of this event cannot be determined.

Event Description

It was reported that they found the locking rings were broken and destroy the nail during surgery.

• Brand Name: REFLEX-HYBRID 1 LEVEL ACP SIZE 18MM
• 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: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4861817
• MDR Text Key: 5852074
• Report Number: 0009617544-2015-00285
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48651118
• Device Lot Number: 143216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• 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