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

Catalog Number	48335308
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the collars broken on both screws.Replaced with new ones.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: manufacturing review was not conducted because no lot number was available.The stryker rep reported that it was a difficult angle and confirmed that the all in one guide was not used as recommended per the stg.Conclusion: the probable root cause of the clip disengagement is due to freehanding.
Event or Problem Description
It was reported that the collars broken on both screws.Replaced with new ones.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 8MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5574786
• Report Number: 3005525032-2016-00041
• Device Sequence Number: 10884167
• Product Code: OVE
• UDI-Device Identifier: 04546540679826
• UDI-Public: (01)04546540679826
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48335308
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 07/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1