MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 1/2X1 -200; SURGICAL PATTIES

Catalog Number 801402

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the surgical patties lost fiber in the patient's tissue during a vertebral column surgery (disk herniation).Surgical delay was reported; however it is unknown for how long.No patient consequences at the time of this report.

Event Description

N/a.

Manufacturer Narrative

The surgical pattie was returned for evaluation: dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the pattie/strip unit was inspected using the unaided eye.No anomalies were observed.Failure analyst inspected the pattie and found that the returned sample was within manufacturing specifications.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Although the complaint could not be confirmed, likely root causes include: poor procedure planning (from not moistening the patties, from moistening the patties for too long, or from not irrigating the patties).

• Brand Name: SURG PAT XRAY 1/2X1 -200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 12054532
• MDR Text Key: 264282945
• Report Number: 3014334038-2021-00123
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801402
• Device Lot Number: 5311135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1