MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-09 for ANCHOR BOLT-LSB STYLE manufactured by Ad-tech Medical Instrument Corp..
[5907825]
Ad-tech received an email and a follow-up email from a customer stating that upon removal of the headwrap to remove the depth electrodes and anchor bolts from the patient, it was noted that one of the electrodes had a broken section of an anchor bolt attached to it. The bolt broke at the level of the outer table of the bone, making it difficult to remove the remaining portion of the bolt that was still within the patient's skull. A nick incision into a two (2) inch incision was made, along with removing some of the outer table of the bone, to allow for the remaining broken piece to be rotated out of the patient. The removal of the remaining portion of the broken bolt lead to a longer removal surgery, however did not result in any neurological harm or increased length of stay. The customer noted that the head wraps are generally changed every other day, making it likely that the broken bolt issue occurred sometime between the two (2) headwraps. The customer also stated that the placement of the broken anchor bolt was near the back of the head (superior parietal), thus he believes the pressure from the back of the head could have broken the belt.
Patient Sequence No: 1, Text Type: D, B5
[13319036]
Ad-tech is currently in the process of investigating this issue. However, as stated in the event description section, the customer did note that the placement of the broken anchor bolt was at the back of the head and thus the customer believes pressure from the back of the head could have broken the bolt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2015-00004 |
| MDR Report Key | 4834482 |
| Report Source | 05 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-08 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2015-07-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 534041876 |
| Manufacturer Country | US |
| Manufacturer Postal | 534041876 |
| Manufacturer Phone | 2626341555 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT-LSB STYLE |
| Product Code | GZL |
| Date Received | 2015-06-09 |
| Returned To Mfg | 2015-05-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM ST. RACINE WI 53404187 US 53404 1876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-09 |