MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-03 for ANCHOR BOLT - DOGALI STYLE DGLK1-18X manufactured by Ad-tech Medical Instrument Corp..
[5894912]
Ad-tech received a letter and follow-up email from a customer stating that one (1) anchor bolt broke during stereotactic placement of bilateral depth electrodes for seizure monitoring on a patient, using the ad-tech placement wrench. A total of thirteen (13) anchor bolts were used during this case. No additional medical interventions were required to address this issue as the broken anchor bolt was removed during the bilateral depth electrode removal surgery. There was no patient harm. The customer stated that the broken bolt was thrown away and the removed retained portion of the bolt was sent to pathology. Ad-tech has made four (4) additional attempts to contact the customer for more information, however the customer has been unresponsive.
Patient Sequence No: 1, Text Type: D, B5
[13392811]
Ad-tech received a letter from (b)(6) med ctr reporting this anchor bolt issue for lot 208140543. A second failure of similar nature was also mentioned in this letter for an anchor bolt from lot 208140545. A separate mdr was filed for this issue under 2183456-2015-00003.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2015-00002 |
| MDR Report Key | 4817953 |
| Report Source | 05 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-28 |
| Date of Event | 2015-03-09 |
| Date Mfgr Received | 2015-04-20 |
| Device Manufacturer Date | 2014-01-16 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT - DOGALI STYLE |
| Generic Name | ANCHOR BOLT, PRODUCT CODE: GCZ |
| Product Code | GYC |
| Date Received | 2015-06-03 |
| Catalog Number | DGLK1-18X |
| Lot Number | 208140543 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM ST. RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-03 |