MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR L LOCKING PLATE LUMBAR STAND ALONE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48667000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had surgery using on (b)(6) 2016 and went to surgeon's office on (b)(6) 2016 for post-op visit.The physician's assistant did a routine ct scan and saw that the plate is "floating" anteriorly in the peritoneal space.The sales rep recalls that the final x-ray of the procedure showed that the locking plate was positioned properly and locked.The surgeon also used the plate feeler to pull up on the plate to ensure it was secure.The surgeon is currently out of town and the rep does not have any further information at this time.Update 10/3/2016: patient will undergo a revision surgery.Not planned yet.
Additional Manufacturer Narrative
Method: risk assessment; result: device inspection, device history review and complaint history review could not be performed as the device was not returned.Conclusion: the plausible cause of the reported event cannot be identified conclusively as neither x-rays nor device were returned for evaluation.
Event or Problem Description
It was reported that the patient had surgery using on (b)(6) 2016 and went to surgeon's office on (b)(6) 2016 for post-op visit.The physician's assistant did a routine ct scan and saw that the plate is "floating" anteriorly in the peritoneal space.The sales rep recalls that the final x-ray of the procedure showed that the locking plate was positioned properly and locked.The surgeon also used the plate feeler to pull up on the plate to ensure it was secure.The surgeon is currently out of town and the rep does not have any further information at this time.Update 10/3/2016.Patient will undergo a revision surgery.Not planned yet.

• Brand Name: ANCHOR L LOCKING PLATE LUMBAR STAND ALONE
• 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: 6034617
• Report Number: 3005525032-2016-00127
• Device Sequence Number: 661075
• Product Code: MAX
• UDI-Device Identifier: 07613252655732
• UDI-Public: (01)07613252655732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48667000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 12/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention