MAUDE Adverse Event Report: INTERPORE CROSS INTERNATIONAL DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER ALLOGRAFT PUTTY

Catalog Number ROAPM20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

One product unit of roapm20, lot 009050, was evaluated for its characteristics. The visual characteristics ¿ color, mixture and uniformity ¿ appeared normal for roapm product. The handling characteristics were very good. The putty was moldable to various shapes, and typical for roapm product. A device history review was performed and no related non-conformances were noted. Roapm20 ¿ lot 009050 ¿ was produced using dbm lot odb-0221600, cancellous lot oba-0221600 and carrier lot 313600. Shop order record indicates that the mixing formulation, dbm, and carrier type are correct. Handling evaluation of the lot sample, as part of the lot release requirements, is acceptable. The complaint was not verifiable, as there were no manufacturing deviations identified with the lot that could cause or contribute to the reported event. Roapm20, lot 009050, was found to have acceptable handling and manufacturing characteristics. No probable cause could be determined.

Manufacturer Narrative

Device was discarded by the customer.

Event Description

The doctor reported that a patient had immediate socket grafting (roapm20) done in tooth location #31 on (b)(6) 2017. The patient returned on (b)(6) 2017 with severe pain, similar to dry socket pain. Loss of graft/non-integration was evident despite covering the site with crisscross sutures & resorbable collagen dressing. The extraction of the allograft was straight forward.

• Brand Name: DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
• Type of Device: ALLOGRAFT PUTTY
• Manufacturer (Section D): INTERPORE CROSS INTERNATIONAL; 181 technology drive; irvine CA 92618 2402
• Manufacturer (Section G): INTERPORE CROSS INTERNATIONAL; 181 technology drive; irvine CA 92618 2402
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6716666
• MDR Text Key: 252094182
• Report Number: 0001038806-2017-00424
• Device Sequence Number: 1
• Product Code: NUN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: ROAPM20
• Device Lot Number: 009050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 07/17/2017 Patient Sequence Number: 1