MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-14 for AUGMENT BONE GRAFT N/A K20003010 manufactured by Biomimetic Therapeutics Llc, Subsidiary Of Wright.
[40250001]
Consumed/implanted during surgery.
Patient Sequence No: 1, Text Type: N, H10
[40250002]
On (b)(6) 2015, a wright medical sales rep (for biomimetic therapeutics, a wholly owned subsidiary of wright medical group) was contacted by a surgeon named dr. (b)(6) regarding any previous reports of swelling and drainage around the incision site on a patient who underwent an ankle fusion, using augment bone graft. Three attempts were made to reach the surgeon to gain additional information relative to the patient outcome, leaving messages with the surgeon's medical assistant requesting a call back. The surgeon's medical assistant called a wright complaint coordinator on (b)(6) 2016, and reported the following: the involved patient is a (b)(6) female, (b)(6), who underwent fusion surgery on (b)(6) 2015 - specific surgical site not reported. The patient was seen in the in the surgeon's office on (b)(6) 2015, and the surgeon performed an incision and drainage of the swollen area. The medical assistant noted during the call on (b)(6)2015 that treatment was ongoing for the patient, and the surgical site was not yet healed post intervention. Wright medical group's medical director contacted dr. (b)(6), and obtained the following additional information: the patient is diabetic and obese; the surgical procedure performed on (b)(6) 2015 was a triple arthrodesis and to date, all joints look as though they have or are healing well; no clinical signs of infection - fluid obtained from the wound was serous without purulence; no hardware was removed during the incision and drainage; the wound was described as healing but not currently healed, and the patient was described as otherwise doing well; the surgeons's only concern was the drainage of serous fluid and his concern as to whether the serous drainage was related to the implant (augment); the surgeon did not have an opinion as to whether or not it was related to augment bone graft but only wondered if that had been seen in other patients. A quality investigation was performed with the report completed on 1/27/2016, based on record review and retain sample evaluation only since the product was completely consumed during the surgery and therefore product was not available to be returned. The conclusion of the investigation was as follows: since the product was not returned, the investigation was limited and the non-specific quality complaint could not be confirmed. The complaint history for augment bone graft indicates no previous history of complaints of this nature. Records including manufacturing records and any deviations were reviewed for this product lot, and revealed that there were no quality concerns during production or at release for this lot. The retain samples and lot release records were evaluated, and the retains showed no quality concerns and the product met all approved specifications at release. Stability studies for this lot have passed all stability testing at intervals up to and including shelf life of 3 years. No further information is available or anticipated. Awareness date of intervention to prevent serious injury: 01/05/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003897776-2016-00001 |
| MDR Report Key | 5498351 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-14 |
| Date of Report | 2016-01-29 |
| Date of Event | 2015-12-04 |
| Date Facility Aware | 2016-01-05 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 2014-05-31 |
| Date Added to Maude | 2016-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANNE WARNER |
| Manufacturer Street | 389 NICHOL MILL LN. |
| Manufacturer City | FRANKLIN TN 37067 |
| Manufacturer Country | US |
| Manufacturer Postal | 37067 |
| Manufacturer Phone | 6162834178 |
| Manufacturer G1 | BIOMIMETIC THERAPEUTICS LLC |
| Manufacturer Street | 389 NICHOL MILL LN. |
| Manufacturer City | FRANKLIN TN 37067 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37067 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUGMENT BONE GRAFT |
| Generic Name | RH-PDGF AND BETA-TCP-BB COMBINATION DRUG DEVICE PRODUCT |
| Product Code | NOX |
| Date Received | 2016-03-14 |
| Model Number | N/A |
| Catalog Number | K20003010 |
| Lot Number | 5/31/17 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 17 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMIMETIC THERAPEUTICS LLC, SUBSIDIARY OF WRIGHT |
| Manufacturer Address | 389 NICHOL MILL LN. FRAANKLIN TN 37067 US 37067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-14 |