MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND (MDR) ANCHOR C DIAM.3.5MM SELF DRILLING 10MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48335310

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Date 07/28/2015

Event Type  malfunction  

Event Description

It was reported that; upon inserting the screws into the cage-the rings stripped.New screws were used successfully.

Manufacturer Narrative

Method: device not returned; results: return of the devices was requested multiple times but they were never received for evaluation.The anchor c surgical technique states that use of a free hand technique is strongly discouraged and use of the guide/inserter tip is required.It was reported that the all in one guide was not being used.Conclusion: the established cause of the event is multifactorial.

Event Description

It was reported that; upon inserting the screws into the cage-the rings stripped.New screws were used successfully.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 10MM
• 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 ; SZ 02300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND (MDR); le crêt-du-locle 10 a; -; la chaux-de-fonds 02300 ; SZ 02300
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5020849
• MDR Text Key: 24673223
• Report Number: 3005525032-2015-00099
• 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: health professional
• Reporter Occupation: Physician
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48335310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• 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