MAUDE Adverse Event Report: BIOMET MICROFIXATION HARD TISSUE REPLACEMENT-PATIENT MATCHED LEFT FRONTAL PARIETAL TEMPORAL; HTR-PMI

Model Number N/A

Device Problems Fitting Problem (2183); Appropriate Term/Code Not Available (3191)

Patient Problems No Code Available (3191); Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

The user facility is foreign; therefore a facility medwatch report will not be available.Review of device history records show the lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.(b)(4).

Event Description

The sales associate reported a revision due to hydrocephalus; an abnormal accumulation of cerebrospinal fluid (csf) in the brain.Additionally, it was reported that independent of the hydrocephalus, the fit of the implant was not correct.During the revision surgery the implant was removed and the back up implant was implanted.

Manufacturer Narrative

Each htr pmma case is shipped with two implants (first choice and a back-up).The revision was for the patient¿s condition of hydrocephalus (accumulation of cerebrospinal fluid).The initial implant was removed to treat the patient¿s condition and the backup implant (designed to the patient¿s anatomy from the initial ct scans) was implanted.The surgeon complained about the fit of this backup implant.There is no allegation that the implant caused the patient¿s condition and the cause of the patient¿s condition (hydrocephalus) will not be investigated.The complaint that the backup implant did not fit was confirmed by the design vendor through the post-op ct scan as there is ¿a gap between the implant and skull is visible around the perimeter of the entire implant.¿ the most likely cause of the complaint as stated by the design vendor is ¿existing bone or soft tissue may have resulted in the improper fit of the implant.¿ there are no indications of manufacturing defects.

• Brand Name: HARD TISSUE REPLACEMENT-PATIENT MATCHED LEFT FRONTAL PARIETAL TEMPORAL
• Type of Device: HTR-PMI
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5360345
• MDR Text Key: 35666674
• Report Number: 0001032347-2016-00006
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2018
• Device Model Number: N/A
• Device Catalogue Number: PM616582
• Device Lot Number: 609440
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention