MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-02 for XEMPLIFI DBM PLUS 8103.0210S manufactured by Allosource.
[96176281]
According to the report from the distributor, an infection had materialized 3 weeks post surgery. The tissue based medical device is aseptically processed, freeze dried, and terminally sterilized via electron beam irradiation. Ninety-two (92) total tissue lots were produced from donor (b)(6): 62 device lots, 19 skin grafts, 2 bone grafts, 9 soft tissue grafts. Eighty-one (81) total lots were distributed: 58 device lots were distributed, 4 used as qc samples; all 19 skin lots were distributed; all 2 bone lots were distributed; 2 soft tissue lots were distributed, and 7 were quarantined. Two lots of tissue based device were implanted into the patient associated with this adverse event (b)(4). Allosource has received no additional reports of adverse reactions or adverse events associated with the other 79 distributed lots. Ninety-one (91) total tissue lots were produced from donor (b)(6): 54 device lots, 28 skin grafts, 9 soft tissue grafts. Seventy-seven (77) total lots were distributed: 48 device lots, 4 used as qc samples, 2 discarded prior to distribution; 26 skin lots were distributed, and 2 were quarantined; 3 soft tissue lots were distributed, and 6 were quarantined. One lot of tissue based device was implanted into the patient associated with this adverse event (b)(4). Allosource has received no additional reports of adverse reactions or adverse events associated with the other 76 distributed lots.
Patient Sequence No: 1, Text Type: N, H10
[96176282]
Three lots of xemplifi dbm plus putty 10 cc, from two donors, manufactured by allosource were implanted into a patient on (b)(6) 2017. On 8/17/2017 the surgeon notified the private label distributor that he was worried that the patient got a staph infection from the "bone graft". Allosource received notification of the incident on 8/30/2017. The three lots of tissue based medical devices remain in the patient. No additional information has been received from the surgeon to date. Three separate adverse event reports are being submitted for the event associated with this patient: 3000215346-2017-00007, 3000215346-2017-00008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000215346-2017-00006 |
| MDR Report Key | 7158008 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-01-02 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2017-04-30 |
| Date Added to Maude | 2018-01-02 |
| 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 | MR. TREVOR WRIGHT |
| Manufacturer Street | 6278 S. TROY CIRCLE |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal | 80111 |
| Manufacturer Phone | 7208734733 |
| Manufacturer G1 | ALLOSOURCE |
| Manufacturer Street | 6278 S. TROY CIRCLE |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80111 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEMPLIFI DBM PLUS |
| Generic Name | BONE VOID FILLLER |
| Product Code | MBP |
| Date Received | 2018-01-02 |
| Model Number | 8103.0210S |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLOSOURCE |
| Manufacturer Address | 6278 S. TROY CIRCLE CENTENNIAL CO 80111 US 80111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-02 |