MAUDE Adverse Event Report: STRYKER SPINE-US UNKNOWN_SPINE_PRODUCT; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number UNK_SPN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/25/2006

Event Type  malfunction  

Event Description

It was reported that a patient had corral packed in her femur after the removal of a benign lesion in 2006.The patient was repacked with a bone graft.The patient is experiencing pain in right femur almost up to the hip, similar pain as prior to repacking with the bone graft.

Manufacturer Narrative

Method: labelling review, risk assessment.Result: the reported device event cannot be confirmed.Catalog and lot number were not provided therefore complaint history review and device history review could not be performed.Device remains implanted and is not available for evaluation.Conclusion: no additional information was received upon multiple attempts therefore it cannot be determined if patients' condition is related to reported device.Since the product failure cannot be confirmed, a root cause of the reported event cannot be determined conclusively.

Event Description

It was reported that a patient had corral packed in her femur after the removal of a benign lesion in 2006.The patient was repacked with a bone graft.The patient is experiencing pain in right femur almost up to the hip, similar pain as prior to repacking with the bone graft.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8112936
• MDR Text Key: 129338948
• Report Number: 0002530131-2018-00003
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: K163621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 91