MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L IMPLANT HOLDER; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48992001

Device Problem Difficult to Remove (1528)

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

Event Date 07/25/2017

Event Type  malfunction  

Event Description

It was reported that; during surgery after releasing the lever implant inserter could not be removed from implant.Implant was able to remove from the inserter by pulling side out with nerve hook.

Manufacturer Narrative

Visual, dimensional and functional analysis could not be performed as the device was not returned.Manufacturing history was reviewed and no issues were identified.The definitive root cause of the event cannot be determined from the given information.

Event Description

It was reported that; during surgery after releasing the lever implant inserter could not be removed from implant.Implant was able to remove from the inserter by pulling side out with nerve hook.

• Brand Name: ANCHOR L IMPLANT HOLDER
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6800029
• MDR Text Key: 83120914
• Report Number: 0009617544-2017-00321
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: 07613252602774
• UDI-Public: (01)07613252602774
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48992001
• Device Lot Number: 131777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1