MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) ANCHOR C DIAM.3.5MM SELF DRILLING 8MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48335308

Device Problems Peeled/Delaminated (1454); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

It was reported that; it was reported that; had two rings on two different screws peel off in same hole.Patient was unaffected.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the reported device confirmed to have a deformed/detached locking ring upon visual inspection of the returned device.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Conclusion: the root cause of the reported event determined, it¿s multifactorial.

Event Description

It was reported that; it was reported that; had two rings on two different screws peel off in same hole.Patient was unaffected.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 8MM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; CH 02300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; CH 02300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4921696
• MDR Text Key: 6026767
• Report Number: 3005525032-2015-00081
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102606
• 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: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 48335308
• Device Lot Number: GSE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2015
• 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