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 PUTTY 8103.0010S manufactured by Allosource.
[96205090]
According to the report from the distributor, an infection had materialized 6 weeks post surgery. The tissue based medical device is aseptically processed, freeze dried, and terminally sterilized via electron beam irradiation. (b)(4) total tissue lots were produced from donor (b)(4): (b)(4) device lots, (b)(4) bone grafts, (b)(4) soft tissue grafts. (b)(4) total lots were distributed: (b)(4) device lots were distributed, (b)(4) used as qc samples; (b)(4) bone lots were distributed, (b)(4) were discarded prior to distribution; all (b)(4) soft tissue lots were distributed. 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 (b)(4) distributed lots. (b)(4) total tissue lots were produced from donor (b)(4): (b)(4) device lots, (b)(4) bone grafts. (b)(4) total lots were distributed: (b)(4) device lots, (b)(4) used as qc samples, (b)(4) discarded prior to distribution; (b)(4) bone lots were distributed, and (b)(4) were quarantined. Three 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 (b)(4) distributed lots. This report was not submitted on the date prepared for submission due to technical issues with esg. These are the first emdrs to be reported electronically by allosource since initiation of the system, and the individual who had the esg account for submission is no longer with the company. Additionally, the original certificate required to initiate the webtrader account with esg was on a device that was decommissioned and it could not reproduce it. These technical issues were discussed with an individual with the emdr group at cdrh who informed the reporter to place a note explaining the technical issues.
Patient Sequence No: 1, Text Type: N, H10
[96205151]
Four lots of xemplifi dbm putty 10cc, from two donors, manufactured by allosource were implanted into a patient on (b)(6) 2017. On (b)(6) 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 (b)(4) 2017. The four lots of tissue based medical devices remain in the patient. No additional information has been received from the surgeon to date. Four separate adverse event reports are being submitted for the event associated with this patient: 3000215346-2017-00009, 3000215346-2017-00010, 3000215346-2017-00011, 3000215346-2017-00012.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000215346-2017-00009 |
| MDR Report Key | 7158034 |
| 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 | 2016-04-11 |
| 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 PUTTY |
| Generic Name | BONE VOID FILLLER |
| Product Code | MBP |
| Date Received | 2018-01-02 |
| Model Number | 8103.0010S |
| Device Expiration Date | 2018-04-11 |
| 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 |