MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number 48335312

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Device Slipped (1584)

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

Event Date 03/14/2017

Event Type  Injury  

Event Description

It was reported that screw backed out, 4months post op.

Manufacturer Narrative

Visual inspection; device history review; complaint history review; risk assessment.Some deformities were found under the locking clip and on the top of the screw.Manufacturing review was performed and no anomalies were identified.The plausible root cause cannot be determined based on the information provided.

Event Description

It was reported that screw backed out, 4 months post op.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; -; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6478086
• MDR Text Key: 72330260
• Report Number: 3005525032-2017-00045
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: (01)04546540679840
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48335312
• Device Lot Number: CDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2016
• 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