MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Model Number 828804PL

Device Problem Crack (1135)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A physician reported a the certas valve (id 828804pl) was implanted on (b)(6) 2022.It was stated that, " looks like siphon guard broken on the ct." therefore, the valve was removed and replaced.

Manufacturer Narrative

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

Manufacturer Narrative

The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr) - the product code 82-8804pl with lot 6025588, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected; the siphon guard was separated from the valve and a cut/tear in the silicon housing along the siphon guard was noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber until the valve casing was noted.The valve could not be reflux tested due to separated siphon guard.The valve passed the test for programming, occlusion, siphon guard and pressure.The siphon guard was visually inspected under microscope at appropriate magnification: a needle mark was noted.The root cause for the problem reported by the customer could probably be due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu, silicone housing has a low cut/tear resistance.

Event Description

N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14757117
• MDR Text Key: 294945022
• Report Number: 3013886523-2022-00284
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)261231(10)6025588
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 828804PL
• Device Catalogue Number: 828804PL
• Device Lot Number: 6025588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1