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

Catalog Number	48335310
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: no relevant manufacturing issues were found for the reported lot.The sales rep reported that the doctor was not using an all in one guide.Conclusion: the plausible root cause is user error.
Event or Problem Description
It was reported that; the surgeon was putting the screws into the cage and before being fully seated the locking ring was coming off.He was not using an all in one guide.We were at c5-6 and c6-7.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 10MM
• 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: 5547246
• Report Number: 3005525032-2016-00032
• Device Sequence Number: 16233771
• Product Code: OVE
• UDI-Device Identifier: 04546540679833
• UDI-Public: (01)04546540679833(11)151118(10)E4Z
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2016

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: 48335310
• Device Lot Number: E4Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2016
• Initial Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1