MAUDE Adverse Event Report: BONALIVE BIOMATERIALS LTD BONALIVE GRANULES; BONE MATRIX IMPLANT, SYNTHETIC

Catalog Number 13XXX

Device Problems Migration or Expulsion of Device (1395); Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

The reason for granules moving / migrating is not known, but one possible option is challenges related to the operation.Ifu states in surgical procedure notes: "prevention of movement and migration of bonalive granules is essential for proper bone formation." and "it is important to have sufficient pre-existing bone wall in the defect and an adequate closure of the graft site (e.G.With cortical bone window, periosteum, collagen membrane, fascia or muscle flap)." and "the above surgical procedure notes are necessary for achieving good application performance and accurate obliteration, and to initiate the bioactive reaction." movement and migration, in turn, are the most probable reasons for inadequate bone formation.Two different products with different granules sizes has been used (2019 and 2021).The causal relationship between the device and the incident is not likely, but it is possible.Note: the 510k is for to catalog number 14xxx.The incident however, concerns catalog number 13xxx, which is not available in us and thus does not have a 510k.However, 13xxx and 14xxx are the same bioactive glass.

Event Description

There is only limited information available.Patient operated twice with bonalive granules (2019 and 2021).Maxillary cyst was removed and filled with bonalive granules.Almost a year after the first operation a granule came out from the upper jaw (complaint reported to manufacturer 22.10.2020).At that time further information from the patient and surgeon was asked, but not received.Incident report was not compiled.New information was received on 9.9.2021 from patient's family member: he reported that a reoperation was made where smaller bonalive granules were implanted.Now 6 months later granule begin to come out again and maxilla has not ossified.Additional information has been asked.

Manufacturer Narrative

Several contact attempts were made towards the complainant and the surgeon, but without success.Additional information was not received.The case remains unresolved.

• Brand Name: BONALIVE GRANULES
• Type of Device: BONE MATRIX IMPLANT, SYNTHETIC
• Manufacturer (Section D): BONALIVE BIOMATERIALS LTD; biolinja 12; turku, 20750 ; FI 20750
• Manufacturer (Section G): BONALIVE BIOMATERIALS LTS; biolinja 12; turku, 20750 ; FI 20750
• Manufacturer Contact: hanna ryosa ; biolinja 12; turku, 20750 ; FI 20750
• MDR Report Key: 12544562
• MDR Text Key: 273739593
• Report Number: 3008328709-2021-00002
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K191274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 13XXX
• Was Device Available for Evaluation?: No
• 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; Other
• Patient Age: 61 YR
• Patient Sex: Female