MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-08 for STRYKER DBM 5 CC GEL manufactured by Allosource.
[123070531]
Donor (b)(4): (b)(4) total lots were produced from donor (b)(4), 8 soft tissue grafts, and (b)(4) device lots. (b)(4) total device lots were distributed and 13 used for qc and validation testing; 3 of the soft tissue grafts were distributed and 5 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 reaction or adverse events associated with the other 25 distributed lots. Donor (b)(4): (b)(4) total lots were produced from donor (b)(4), 2 soft tissue grafts, 28 device lots, 17 bone grafts and 11 skin grafts. (b)(4) device lots were distributed and 4 were used for qc testing; 2 soft tissue lots were distributed and 1 quarantined. 4 bone lots were distributed and 13 were quarantined. All 11 skin 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 40 distributed lots. On 8/13/2018 allosource quality assurance lab assembly and analysis of all environmental data associated with the donor processing indicates that the clean room environment did not have a negative impact on the quality of the tissue. On 8/22/2018 allosource md review of the donor indicates recovery/preprocessing cultures showed 4 of the 24 grafts positive for propionibacterium acnes the remaining 20 grafts showed no growth, all serologies were negative and the donor met all requirements for processing. On 8/13/"1981" allosource suitability review indicates that the donor met all release criteria in that all procurement and final cultures were negative or suitable for microbial growth. On 8/13/2018 and 8/14/"2013" allosource review of the processing job record and irradiation job record indicates that the lot was processed, cleansed, packaged and irradiated according to procedure. The 2 grafts referenced in report underwent bioburden reduction cleanse and were terminally sterilized with a validated e-beam irradiation process. Additionally, please note that this report is filed late due to many technical difficulties throughout the enrollment process.
Patient Sequence No: 1, Text Type: N, H10
[123070532]
Two lots of stryker dbm gel 5cc from two different donors, manufactured by allosource were implanted into a patient on (b)(6) 2018. On (b)(6) 2018 the surgeon notified the private label distributor that the patient developed an infection of unknown origin and that the infecting microorganism was unknown. Allosource received notification of the incident on august 2, 2018. The 2 lots of tissue based medical device remain in the patient. Additional information received from the surgeon indicated that on (b)(6) 2017, the patient underwent an arthrodosis subtalor joint procedure. On (b)(6) 2017 the patient presented with symptoms; (b)(6) 2017 the patient was readmitted, the surgical wound debrided; cultures taken from the wound site tested positive for enterobacter cloacae.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000215346-2018-00004 |
| MDR Report Key | 7942529 |
| Date Received | 2018-10-08 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2017-09-24 |
| Date Added to Maude | 2018-10-08 |
| 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 GRETCHEN MCGOFFIN |
| Manufacturer Street | 6278 S TROY CIRCLE |
| Manufacturer City | CENTENNIAL CO 80111 |
| Manufacturer Country | US |
| Manufacturer Postal | 80111 |
| Manufacturer Phone | 7208734750 |
| Manufacturer G1 | ALLOSOURCE |
| Manufacturer Street | 6278 S TROY CIRCLE |
| Manufacturer City | CENTENNIAL 80111 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER DBM 5 CC GEL |
| Generic Name | BONE VOID FILLER, PRODICT CODE MBP |
| Product Code | MBP |
| Date Received | 2018-10-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLOSOURCE |
| Manufacturer Address | 6278 S TROY CIRCLE CENTENNIAL 80111 US 80111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-08 |