MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; UNKNOWN SPINE PRODUCT

Catalog Number UNK_SPN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 06/09/2015

Event Type  Injury  

Event Description

It was reported that, plif of l4-s with xia lp was performed.Last year, low back pain appeared on the patient and stenosis of l3/4 was confirmed.Extension of fixation to l3 with xia3 and plif was performed.

Manufacturer Narrative

Method: device was not returned.Results: device history review could not be performed as no lot code was provided.Device inspection could not be performed as no device was returned.Conclusion: the root cause of the reported event could not be determined because no device and/or insufficient information was provided for review.

Event Description

It was reported that, plif of l4-s with xia lp was performed.Last year, low back pain appeared on the patient and stenosis of l3/4 was confirmed.Extension of fixation to l3 with xia3 and plif was performed.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: UNKNOWN SPINE PRODUCT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: irma gamonal ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4887441
• MDR Text Key: 19436268
• Report Number: 0009617544-2015-00309
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/09/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR